FDA Device recall Z-0223-2016

FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a…

FDA Device
Class II
terminated
Published 2015-11-11

On 2015-11-11 the FDA classified a Class II recall of FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a… by Bard Peripheral Vascular, citing 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 o….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0223-2016
Classification	Class II
Status	terminated
Initiated	2015-10-19
Published	2015-11-11
Last updated	2026-09-13 11:53 UTC
Company	Bard Peripheral Vascular
Distribution	US

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.

Identifiers

code_info	Product Code: FAF08070, Lot No. ANWJ3216 ANXD0762 ANXI2396 ANYG0316 ANWJ3217 ANXD1279 ANXI3475 ANYG06… Product Code: FAF08070, Lot No. ANWJ3216 ANXD0762 ANXI2396 ANYG0316 ANWJ3217 ANXD1279 ANXI3475 ANYG0654 ANWK0056 ANXD1280 ANXJ1793 ANYG1630 ANWK0057 ANXD1641 ANXJ2700 ANYG3413 ANWK0058 ANXD1642 ANXK0641 ANYG3414 ANWK0567 ANXD1643 ANXK3033 ANYH0028 ANWK0568 ANXD1644 ANXL0612 ANYH0029 ANWK0569 ANXD2494 ANXL0947 ANYH0982 ANWK0570 ANXD2495 ANXL1451 ANYH0983 ANWK0571 ANXD2496 ANXL1752 ANYH2304 ANWK0572 ANXD2992 ANXL1865 ANYH3647 ANWK2441 ANXD2993 ANYA0042 ANYI2267 ANWK2442 ANXD2994 ANYA0050 ANYI2914 ANWK2443 ANXE0280 ANYA0933 ANYJ0077 ANWK2444 ANXE0281 ANYA1633 ANYJ1318 ANWK2445 ANXE0282 ANYA2052 ANYJ1833 ANWK3391 ANXE0652 ANYA2370 ANYJ2864 ANWK3809 ANXE0653 ANYA2531 ANYK0724 ANWK3810 ANXE0654 ANYB0456 ANYK1157 ANWL0501 ANXE0655 ANYB1022 ANYK2348 ANWL0502 ANXE1453 ANYB2410 ANYK3056 ANWL0507 ANXE2049 ANYB3171 ANZB1342 ANWL0508 ANXE

code_info

Product Code: FAF08070, Lot No. ANWJ3216 ANXD0762 ANXI2396 ANYG0316 ANWJ3217 ANXD1279 ANXI3475 ANYG06…

Product Code: FAF08070, Lot No. ANWJ3216 ANXD0762 ANXI2396 ANYG0316 ANWJ3217 ANXD1279 ANXI3475 ANYG0654 ANWK0056 ANXD1280 ANXJ1793 ANYG1630 ANWK0057 ANXD1641 ANXJ2700 ANYG3413 ANWK0058 ANXD1642 ANXK0641 ANYG3414 ANWK0567 ANXD1643 ANXK3033 ANYH0028 ANWK0568 ANXD1644 ANXL0612 ANYH0029 ANWK0569 ANXD2494 ANXL0947 ANYH0982 ANWK0570 ANXD2495 ANXL1451 ANYH0983 ANWK0571 ANXD2496 ANXL1752 ANYH2304 ANWK0572 ANXD2992 ANXL1865 ANYH3647 ANWK2441 ANXD2993 ANYA0042 ANYI2267 ANWK2442 ANXD2994 ANYA0050 ANYI2914 ANWK2443 ANXE0280 ANYA0933 ANYJ0077 ANWK2444 ANXE0281 ANYA1633 ANYJ1318 ANWK2445 ANXE0282 ANYA2052 ANYJ1833 ANWK3391 ANXE0652 ANYA2370 ANYJ2864 ANWK3809 ANXE0653 ANYA2531 ANYK0724 ANWK3810 ANXE0654 ANYB0456 ANYK1157 ANWL0501 ANXE0655 ANYB1022 ANYK2348 ANWL0502 ANXE1453 ANYB2410 ANYK3056 ANWL0507 ANXE2049 ANYB3171 ANZB1342 ANWL0508 ANXE

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0223-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.