FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Gr

FDA device recall Z-0223-2016 · posted 2015-11-05 · Terminated

Recall details

Recalling firm

Bard Peripheral Vascular Inc

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.

Action taken

Bard sent an Urgent Medical Device Recall Notification letter dated October 19, 2015, to customers who received the Bard Flair Endovascular Stent Grant. The letter informs customers that the harm associated with failure to deploy or deployment related issues that could occur during use may pose an incremental risk to the already inherit risk associated with stent graft procedures. The letter also provides customers with the actions to be taken. Customers were instructed to call Bard Peripheral Vascular's (BPV) Recall Coordinator at 1-800-321-4254 Option #2 Ext 2501 (M-F 6am to 3pm MST). Customers were instructed to fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772.

Root cause

Device Design

Status

Terminated

Product code

MIH

Quantity affected

292 units

Distribution

Nationwide in US

Date initiated

2015-10-19

Date posted

2015-11-05

Date terminated

2016-04-12

Location

Tempe, AZ