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

FDA Device Recall #Z-0223-2016 — Class II — October 19, 2015

Recall Summary

Recall Number Z-0223-2016
Classification Class II — Moderate risk
Date Initiated October 19, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bard Peripheral Vascular Inc
Location Tempe, AZ
Product Type Devices
Quantity 292 units

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.

Distribution Pattern

Nationwide in US

Lot / Code Information

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 ANXH1586 ANYE1280 ANXB4024 ANXH1587 ANYE2757 ANXB4025 ANXH2842 ANYE3276 ANXB4026 ANXH3098 ANYF0203 ANXC0523 ANXH3100 ANYF0243 ANXD0758 ANXI0375 ANYF2027 ANXD0759 ANXI1296 ANYF2028 ANXD0760 ANXI1298 ANYF2411 ANXD0761 ANXI2395 ANYF3184 Product Code: FAS08070 Lot No. ANWJ3097 ANXC2796 ANYA0036 ANYK2342 ANWJ3098 ANXC2797 ANYA0037 ANYK3044 ANWJ3099 ANXD0029 ANYA0939 ANZB1349 ANWK0580 ANXD0030 ANYA2054 ANZB1350 ANWK0581 ANXD0031 ANYA2678 ANZB1351 ANWK0582 ANXD0032 ANYA3222 ANWK0583 ANXD2812 ANYB0453 ANWK1097 ANXD4188 ANYB1024 ANWK1098 ANXD4189 ANYB2414 ANWK1099 ANXD4607 ANYB3174 ANWK1100 ANXE1146 ANYB3177 ANWK1101 ANXE1147 ANYB3178 ANWK2446 ANXE1465 ANYC0218 ANWK2447 ANXE1466 ANYC1998 ANWK3392 ANXE3173 ANYC2328 ANWK3393 ANXF0156 ANYD2752 ANWK3394 ANXF1333 ANYD3371 ANWK3570 ANXF2407 ANYE0228 ANWK3571 ANXF2408 ANYE1278 ANWK3572 ANXF2866 ANYE2516 ANWK3811 ANXG0229 ANYE3282 ANWK3812 ANXG1416 ANYF0204 ANWK4023 ANXG2513 ANYF0247 ANWK4024 ANXH1078 ANYF2025 ANWL0504 ANXH1589 ANYF2621 ANWL0505 ANXH3102 ANYF3189 ANWL0506 ANXI0389 ANYG1006 ANWL1086 ANXI1336 ANYG1939 ANXA0679 ANXI2405 ANYG2864 ANXB0898 ANXJ1254 ANYG3426 ANXB0899 ANXJ1795 ANYG3427 ANXB1372 ANXJ2068 ANYG3428 ANXB1373 ANXJ2709 ANYH0039 ANXB1374 ANXJ2710 ANYH3655 ANXB1584 ANXK0651 ANYI0669 ANXB1585 ANXK0652 ANYI0677 ANXB1586 ANXK1600 ANYI1452 ANXB3283 ANXK1601 ANYI2270 ANXB3284 ANXK2564 ANYJ0072 ANXB3285 ANXK3027 ANYJ0085 ANXC1568 ANXL0427 ANYJ1334 ANXC1569 ANXL1186 ANYJ1839 ANXC1871 ANXL1450 ANYJ2873 ANXC1872 ANXL1867 ANYK1155

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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