Recall Z-0223-2016
Bard Peripheral Vascular Inc · initiated October 19, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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 ANXE2050 ANYB3172 ANZC0859 ANWL0509 ANXE3161 ANYB3509 ANXA0088 ANXF0165 ANYB3510 ANXA0089 ANXF0166 ANYC0062 ANXA0924 ANXF1325 ANYC2197 ANXA0925 ANXF1326 ANYD0186 ANXA3026 ANXF2393 ANYD0187 ANXB0438 ANXF2394 ANYD0725 ANXB0439 ANXF2395 ANYD1177 ANXB0440 ANXG0227 ANYD1906 ANXB3276 ANXG1407 ANYD2532 ANXB3277 ANXG2477 ANYD3370 ANXB3278 ANXH1052 ANYE0227 ANXB3279…
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0223-2016
- Initiated
- October 19, 2015
- Posted by FDA
- November 5, 2015
- Terminated
- April 12, 2016
- Product code
- MIH – System, Endovascular Graft, Aortic Aneurysm Treatment
- Quantity
- 292 units
- Distribution
- Nationwide in US
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ