Recall Z-0223-2016— Bard Peripheral Vascular Inc
Class II · Terminated
Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2015-10-19, terminated 2016-04-12. FDA's recall record names no specific 510(k) clearance for this event. Product: FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is available in both flared and straight configurations. The distal end of the flared configuration devices are approximately 4mm larger in diameter than the body section.. Reason: Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues that could occur during use..
- Recalling firm
- Bard Peripheral Vascular Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-19
- Terminated
- 2016-04-12
- Firm location
- Tempe, AZ, United States
Product description
FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is available in both flared and straight configurations. The distal end of the flared configuration devices are approximately 4mm larger in diameter than the body section.
Reason for recall
Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues that could occur during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.