The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
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Implants & Prosthetics
🏥 Medical Devices • 4,540 recalls
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Cook Medical Incorporated
Class I - Dangerous
Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event
Class I - Dangerous
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
St Jude Medical Cardiac Rhythm Management Division
Class I - Dangerous
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
Class I - Dangerous
PMMA is listed as a material on the label but the product does not contain PMMA.
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
Boston Scientific
Class I - Dangerous
The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Boston Scientific
Class I - Dangerous
The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
Class I - Dangerous
Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
Zimmer Manufacturing B.V.
Class I - Dangerous
A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3.