Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.

Class I - Dangerous

🏥 Medical Devices Recalled: November 25, 2024 Spectranetics Surgical Instruments Nationwide

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Model Number / 12NC / Product Description 414-151 / 989930000531 / 1.4 mm OTW Lot Numbers / UDI codes: FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY24B09A 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(01)00813132024710(17)251211(10)FAY23M06A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H0
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Spectranetics Corporation
Reason for Recall:: Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.

Product Codes/Lot Numbers:

Model Number / 12NC / Product Description 414-151 / 989930000531 / 1.4 mm OTW Lot Numbers / UDI codes: FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23M06A 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(01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H0

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0680-2025

Related Recalls

Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061; Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 156080062

Spectranetics

Class I - Dangerous

Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.

Jan 10, 2025 Implants & Prosthetics Nationwide View Details →

Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152 The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.

Spectranetics

Class I - Dangerous

Incorrect product labeling. Exterior product box label does not match internal pouch label.

Nov 15, 2023 Surgical Instruments Nationwide View Details →

Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.

Spectranetics

Class I - Dangerous

Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.

Oct 14, 2022 Implants & Prosthetics Nationwide View Details →