Bard Peripheral Vascular Inc recalls FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent G…

Recall date

October 19, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0223-2016

FDA classification

Class II

Brand / firm

Bard Peripheral Vascular Inc

Sold / distributed

Nationwide in US

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.