FLAIR Endovascular Stent Graft
Medical device recall Z-0223-2016. Published in FDA’s Enforcement Report on Nov 11, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 11, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 292 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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.
292 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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…
FDA’s list runs to 2,690 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide in US
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 19, 2015.
- FDA classified it on Nov 5, 2015.
- FDA’s Enforcement Report published it on Nov 11, 2015.
- FDA terminated it on Apr 12, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Bard Peripheral Vascular Inc, of Tempe, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,690 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.