Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

Class I - Dangerous

🏥 Medical Devices Recalled: January 11, 2022 TELEFLEX MEDICAL Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
Lot Number / UDI: 13F20A0286 / (01)00801902013156(17)211231(10)13F20A0286; Lot Number / UDI: 13F20A0426 / (01)00801902013156(17)211231(10)13F20A0426; Lot Number / UDI: 13F20A0640 / (01)00801902013156(17)220131(10)13F20A0640; Lot Number / UDI: 13F20B0141 / (01)00801902013156(17)220131(10)13F20B0141; Lot Number / UDI: 13F20B0276 / (01)00801902013156(17)220228(10)13F20B0276; Lot Number / UDI: 13F20B0353 / (01)00801902013156(17)220228(10)13F20B0353; Lot Number / UDI: 13F20B0424 / (01)00801902013156(17)220228(10)13F20B0424; Lot Number / UDI: 13F20C0352 / (01)00801902013156(17)220228(10)13F20C0352; Lot Number / UDI: 13F20C0425 / (01)00801902013156(17)220331(10)13F20C0425; Lot Number / UDI: 13F20C0426 / (01)00801902013156(17)220331(10)13F20C0426; Lot Number / UDI: 13F20D0122 / (01)00801902013156(17)220331(10)13F20D0122; Lot Number / UDI: 13F20D0123 / (01)00801902013156(17)220430(10)13F20D0123; Lot Number / UDI: 13F20D0124 / (01)00801902013156(17)220331(10)13F20D0124; Lot Number / UDI: 13F20D0403 / (01)00801902013156(17)220430(10)13F20D0403; Lot Number / UDI: 13F20E0204 / (01)00801902013156(17)220430(10)13F20E0204; Lot Number / UDI: 13F20F0232 / (01)00801902013156(17)220531(10)13F20F0232; Lot Number / UDI: 13F20F0389 / (01)00801902013156(17)220630(10)13F20F0389; Lot Number / UDI: 13F20G0353 / (01)00801902013156(17)220630(10)13F20G0353; Lot Number / UDI: 13F20H0729 / (01)00801902013156(17)220831(10)13F20H0729; Lot Number / UDI: 13F20J0378 / (01)00801902013156(17)220831(10)13F20J0378; Lot Number / UDI: 13F20J0546 / (01)00801902013156(17)220831(10)13F20J0546; Lot Number / UDI: 13F20J0771 / (01)00801902013156(17)220831(10)13F20J0771; Lot Number / UDI: 13F20K0503 / (01)00801902013156(17)220930(10)13F20K0503; Lot Number / UDI: 13F20K0504 / (01)00801902013156(17)220930(10)13F20K0504; Lot Number / UDI: 13F20K0630 / (01)00801902013156(17)220930(10)13F20K0630; Lot Number / UDI: 13F20K0631 / (01)00801902013156(17)220930(10)13F20K0631; Lot Number / UDI: 13F20M0175 / (01)00801902013156(17)221130(10)13F20M0175; Lot Number / UDI: 13F20M0176 / (01)00801902013156(17)221130(10)13F20M0176; Lot Number / UDI: 13F20M0177 / (01)00801902013156(17)221130(10)13F20M0177; Lot Number / UDI: 13F20M0178 / (01)10801902013153(17)221130(10)13F20M0178; Lot Number / UDI: 13F20M0181 / (01)00801902013156(17)221231(10)13F20M0181; Lot Number / UDI: 13F21A0352 / (01)00801902013156(17)221231(10)13F21A0352; Lot Number / UDI: 13F21B0159 / (01)00801902013156(17)230131(10)13F21B0159; Lot Number / UDI: 13F21B0222 / (01)00801902013156(17)230131(10)13F21B0222; Lot Number / UDI: 13F21B0519 / (01)10801902013153(17)230228(10)13F21B0519; Lot Number / UDI: 13F21C0364 / (01)00801902013156(17)230228(10)13F21C0364; Lot Number / UDI: 13F21C0365 / (01)00801902013156(17)230228(10)13F21C0365; Lot Number / UDI: 13F21D0462 / (01)00801902013156(17)230331(10)13F21D0462; Lot Number / UDI: 13F21E0079 / (01)00801902013156(17)230430(10)13F21E0079; Lot Number / UDI: 13F21E0259 / (01)00801902013156(17)230430(10)13F21E0259; Lot Number / UDI: 13F21E0260 / (01)00801902013156(17)230430(10)13F21E0260; Lot Number / UDI: 13F21E0556 / (01)00801902013156(17)230430(10)13F21E0556; Lot Number / UDI: 13F21F0641 / (01)00801902013156(17)230531(10)13F21F0641; Lot Number / UDI: 13F21G0227 / (01)00801902013156(17)230630(10)13F21G0227; Lot Number / UDI: 13F21G0401 / (01)00801902013156(17)230630(10)13F21G0401; Lot Number / UDI: 13F21G0772 / (01)00801902013156(17)230630(10)13F21G0772; Lot Number / UDI: 13F21H0447 / (01)10801902194074(17)230731(10)13F21H0447; Lot Number / UDI: 13F21K0827 / (01)10801902194074(17)231031(10)13F21K0827; Lot Number / UDI: 13F21K0898 / (01)10801902194074(17)231031(10)13F21K0898; Lot Number / UDI: 13F21L0227 / (01)20801902194071(17)231031(10)13F21L0227; Lot Number / UDI: 13F21L0507 / (01)10801902194074(17)231031(10)13F21L0507; Lot Number / UDI: 13F21L0898 / (01)10801902194074(17)231031(10)13F21L0898
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:: TELEFLEX MEDICAL INC
Reason for Recall:: The firm received reports indicating PTD tip separation during use.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

Product Codes/Lot Numbers:

Lot Number / UDI: 13F20A0286 / (01)00801902013156(17)211231(10)13F20A0286; Lot Number / UDI: 13F20A0426 / (01)00801902013156(17)211231(10)13F20A0426; Lot Number / UDI: 13F20A0640 / (01)00801902013156(17)220131(10)13F20A0640; Lot Number / UDI: 13F20B0141 / (01)00801902013156(17)220131(10)13F20B0141; Lot Number / UDI: 13F20B0276 / (01)00801902013156(17)220228(10)13F20B0276; Lot Number / UDI: 13F20B0353 / (01)00801902013156(17)220228(10)13F20B0353; Lot Number / UDI: 13F20B0424 / (01)00801902013156(17)220228(10)13F20B0424; Lot Number / UDI: 13F20C0352 / (01)00801902013156(17)220228(10)13F20C0352; Lot Number / UDI: 13F20C0425 / (01)00801902013156(17)220331(10)13F20C0425; Lot Number / UDI: 13F20C0426 / (01)00801902013156(17)220331(10)13F20C0426; Lot Number / UDI: 13F20D0122 / (01)00801902013156(17)220331(10)13F20D0122; Lot Number / UDI: 13F20D0123 / (01)00801902013156(17)220430(10)13F20D0123; Lot Number / UDI: 13F20D0124 / (01)00801902013156(17)220331(10)13F20D0124; Lot Number / UDI: 13F20D0403 / (01)00801902013156(17)220430(10)13F20D0403; Lot Number / UDI: 13F20E0204 / (01)00801902013156(17)220430(10)13F20E0204; Lot Number / UDI: 13F20F0232 / (01)00801902013156(17)220531(10)13F20F0232; Lot Number / UDI: 13F20F0389 / (01)00801902013156(17)220630(10)13F20F0389; Lot Number / UDI: 13F20G0353 / (01)00801902013156(17)220630(10)13F20G0353; Lot Number / UDI: 13F20H0729 / (01)00801902013156(17)220831(10)13F20H0729; Lot Number / UDI: 13F20J0378 / (01)00801902013156(17)220831(10)13F20J0378; Lot Number / UDI: 13F20J0546 / (01)00801902013156(17)220831(10)13F20J0546; Lot Number / UDI: 13F20J0771 / (01)00801902013156(17)220831(10)13F20J0771; Lot Number / UDI: 13F20K0503 / (01)00801902013156(17)220930(10)13F20K0503; Lot Number / UDI: 13F20K0504 / (01)00801902013156(17)220930(10)13F20K0504; Lot Number / UDI: 13F20K0630 / (01)00801902013156(17)220930(10)13F20K0630; Lot Number / UDI: 13F20K0631 / (01)00801902013156(17)220930(10)13F20K0631; Lot Number / UDI: 13F20M0175 / (01)00801902013156(17)221130(10)13F20M0175; Lot Number / UDI: 13F20M0176 / (01)00801902013156(17)221130(10)13F20M0176; Lot Number / UDI: 13F20M0177 / (01)00801902013156(17)221130(10)13F20M0177; Lot Number / UDI: 13F20M0178 / (01)10801902013153(17)221130(10)13F20M0178; Lot Number / UDI: 13F20M0181 / (01)00801902013156(17)221231(10)13F20M0181; Lot Number / UDI: 13F21A0352 / (01)00801902013156(17)221231(10)13F21A0352; Lot Number / UDI: 13F21B0159 / (01)00801902013156(17)230131(10)13F21B0159; Lot Number / UDI: 13F21B0222 / (01)00801902013156(17)230131(10)13F21B0222; Lot Number / UDI: 13F21B0519 / (01)10801902013153(17)230228(10)13F21B0519; Lot Number / UDI: 13F21C0364 / (01)00801902013156(17)230228(10)13F21C0364; Lot Number / UDI: 13F21C0365 / (01)00801902013156(17)230228(10)13F21C0365; Lot Number / UDI: 13F21D0462 / (01)00801902013156(17)230331(10)13F21D0462; Lot Number / UDI: 13F21E0079 / (01)00801902013156(17)230430(10)13F21E0079; Lot Number / UDI: 13F21E0259 / (01)00801902013156(17)230430(10)13F21E0259; Lot Number / UDI: 13F21E0260 / (01)00801902013156(17)230430(10)13F21E0260; Lot Number / UDI: 13F21E0556 / (01)00801902013156(17)230430(10)13F21E0556; Lot Number / UDI: 13F21F0641 / (01)00801902013156(17)230531(10)13F21F0641; Lot Number / UDI: 13F21G0227 / (01)00801902013156(17)230630(10)13F21G0227; Lot Number / UDI: 13F21G0401 / (01)00801902013156(17)230630(10)13F21G0401; Lot Number / UDI: 13F21G0772 / (01)00801902013156(17)230630(10)13F21G0772; Lot Number / UDI: 13F21H0447 / (01)10801902194074(17)230731(10)13F21H0447; Lot Number / UDI: 13F21K0827 / (01)10801902194074(17)231031(10)13F21K0827; Lot Number / UDI: 13F21K0898 / (01)10801902194074(17)231031(10)13F21K0898; Lot Number / UDI: 13F21L0227 / (01)20801902194071(17)231031(10)13F21L0227; Lot Number / UDI: 13F21L0507 / (01)10801902194074(17)231031(10)13F21L0507; Lot Number / UDI: 13F21L0898 / (01)10801902194074(17)231031(10)13F21L0898