Recall archive / FDA device enforcement
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a niti... — FDA record Z-1108-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 22, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
- Reason
- An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
- Classification
- Class II
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 10,815 devices (U.S. total)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1108-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog Numbers/UDI Codes/Lot_Serial Numbers: AVFM06040 (01)00801741106422(17)230806(10)ANFV0313 (01)00801741106422(17)231105(10)ANFY0615 (01)00801741106422(17)231112(10)ANFY1670 ANFV0313 ANFY0615 ANFY1670 AVFM06080 (01)00801741106446(17)231001(10)ANFX0083 ANFX0083 AVFM06100 (01)00801741106453(17)230625(10)ANFT3586 (01)00801741106453(17)230924(10)ANFW3143 ANFT3586 ANFW3143 AVFM07040 (01)00801741106460(17)230618(10)ANFT2594 (01)00801741106460(17)230728(10)ANFU3611 (01)00801741106460(17)230804(10)ANFV0172 (01)00801741106460(17)231101(10)ANFY0004 (01)00801741106460(17)231105(10)ANFY0616 ANFT2594 ANFU3611 ANFV0172 ANFY0004 ANFY0616 AVFM07060 (01)00801741106477(17)230611(10)ANFT1469 (01)00801741106477(17)230618(10)ANFT2644 (01)00801741106477(17)230702(10)ANFU0185 (01)00801741106477(17)230709(10)ANFU1105 (01)00801741106477(17)230722(10)ANFU2677 (01)00801741106477(17)230804(10)ANFV0168 (01)00801741106477(17)230809(10)ANFV0764 (01)00801741106477(17)230809(10)ANFV0844 (01)00801741106477(17)231007(10)ANFX1081 (01)00801741106477(17)231026(10)ANFX3588 (01)00801741106477(17)231029(10)ANFX4098 ANFT1469 ANFT2644 ANFU0185 ANFU1105 ANFU2677 ANFV0168 ANFV0764 ANFV0844 ANFX1081 ANFX3588 ANFX4098 AVFM07080 (01)00801741106484(17)230611(10)ANFT1470 (01)00801741106484(17)230722(10)ANFU2678 (01)00801741106484(17)231103(10)ANFY0162 (01)00801741106484(17)231105(10)ANFY0655 ANFT1470 ANFU2678 ANFY0162 ANFY0655 AVFM07100 (01)00801741106491(17)230722(10)ANFU2681 (01)00801741106491(17)230917(10)ANFW2013 (01)00801741106491(17)231029(10)ANFX4135 (01)00801741106491(17)231112(10)ANFY1672 ANFU2681 ANFW2013 ANFX4135 ANFY1672 AVFM08040 (01)00801741106507(17)230604(10)ANFT0451 (01)00801741106507(17)230611(10)ANFT1471 (01)00801741106507(17)230618(10)ANFT2595 (01)00801741106507(17)230702(10)ANFU0186 (01)00801741106507(17)230716(10)ANFU2274 (01)00801741106507(17)230721(10)ANFU2533 (01)00801741106507(17)230804(10)ANFV0169 (01)00801741106507(17)230804(10)ANFV0174 (01)00801741106507(17)230809(10)ANFV0765 (01)00801741106507(17)230813(10)ANFV0992 (01)00801741106507(17)231007(10)ANFX1082 (01)00801741106507(17)231008(10)ANFX1455 (01)00801741106507(17)231101(10)ANFY0003 (01)00801741106507(17)231105(10)ANFY0617 (01)00801741106507(17)231216(10)ANFZ1835 ANFT0451 ANFT1471 ANFT2595 ANFU0186 ANFU2274 ANFU2533 ANFV0169 ANFV0174 ANFV0765 ANFV0992 ANFX1082 ANFX1455 ANFY0003 ANFY0617 ANFZ1835 AVFM08060 (01)00801741106514(17)230604(10)ANFT0452 (01)00801741106514(17)230611(10)ANFT1472 (01)00801741106514(17)230618(10)ANFT2645 (01)00801741106514(17)230702(10)ANFU0160 (01)00801741106514(17)230702(10)ANFU0183 (01)00801741106514(17)230709(10)ANFU1073 (01)00801741106514(17)230722(10)ANFU2679 (01)00801741106514(17)230730(10)ANFU3900 (01)00801741106514(17)230804(10)ANFV0170 (01)00801741106514(17)230806(10)ANFV0247 (01)00801741106514(17)230809(10)ANFV0766 (01)00801741106514(17)230809(10)ANFV0841 (01)00801741106514(17)230813(10)ANFV0990 (01)00801741106514(17)230917(10)ANFW2014 (01)00801741106514(17)230924(10)ANFW3144 (01)00801741106514(17)231001(10)ANFX0075 (01)00801741106514(17)231007(10)ANFX1080 (01)00801741106514(17)231008(10)ANFX1456 (01)00801741106514(17)231028(10)ANFX3740 (01)00801741106514(17)231029(10)ANFX4099 (01)00801741106514(17)231111(10)ANFY1507 (01)00801741106514(17)231112(10)ANFY1673 ANFT0452 ANFT1472 ANFT2645 ANFU0160 ANFU0183 ANFU1073 ANFU2679 ANFU3900 ANFV0170 ANFV0247 ANFV0766 ANFV0841 ANFV0990 ANFW2014 ANFW3144 ANFX0075 ANFX1080 ANFX1456 ANFX3740 ANFX4099 ANFY1507 ANFY1673 AVFM08080 (01)00801741106521(17)230604(10)ANFT0469 (01)00801741106521(17)230611(10)ANFT1473 (01)00801741106521(17)230618(10)ANFT2646 (01)00801741106521(17)230716(10)ANFU2244 (01)00801741106521(17)230723(10)ANFU2724 (01)00801741106521(17)230723(10)ANFU2984 (01)00801741106521(17)230903(10)ANFW0161 (01)00801741106521(17)230917(10)ANFW2015 (01)00801741106521(17)230924(10)ANFW3145 (01)00801741106521(17)231008(10)ANFX1457 (01)00801741106521(17)231015(10)ANFX2040 (01)00801741106521(17)231015(10)ANFX2271 (01)00801741106521(17)231105(10)ANFY0618 ANFT0469 ANFT1473 ANFT2646 ANFU2244 ANFU2724 ANFU2984 ANFW0161 ANFW2015 ANFW3145 ANFX1457 ANFX2040 ANFX2271 ANFY0618 AVFM08100 (01)00801741106538(17)230604(10)ANFT0489 (01)00801741106538(17)230709(10)ANFU1074 (01)00801741106538(17)230722(10)ANFU2680 (01)00801741106538(17)230823(10)ANFV2290 (01)00801741106538(17)230924(10)ANFW3146 (01)00801741106538(17)231101(10)ANFY0002 (01)00801741106538(17)231105(10)ANFY0619 (01)00801741106538(17)231216(10)ANFZ1834 ANFT0489 ANFU1074 ANFU2680 ANFV2290 ANFW3146 ANFY0002 ANFY0619 ANFZ1834 AVFM09040 (01)00801741106545(17)230604(10)ANFT0470 (01)00801741106545(17)230611(10)ANFT1474 (01)00801741106545(17)230618(10)ANFT2596 (01)00801741106545(17)230721(10)ANFU2535 (01)00801741106545(17)230823(10)ANFV2291 (01)00801741106545(17)230924(10)ANFW3147 (01)00801741106545(17)231015(10)ANFX2042 (01)00801741106545(17)231015(10)ANFX2272 ANFT0470 ANFT1474 ANFT2596 ANFU2535 ANFV2291 ANFW3147 ANFX2042 ANFX2272 AVFM09060 (01)00801741106552(17)230604(10)ANFT0487 (01)00801741106552(17)230611(10)ANFT1475 (01)00801741106552(17)230618(10)ANFT2597 (01)00801741106552(17)230628(10)ANFT3760 (01)00801741106552(17)230702(10)ANFU0161 (01)00801741106552(17)230709(10)ANFU1106 (01)00801741106552(17)230723(10)ANFU2985 (01)00801741106552(17)230728(10)ANFU3452 (01)00801741106552(17)230730(10)ANFU3901 (01)00801741106552(17)230809(10)ANFV0842 (01)00801741106552(17)230817(10)ANFV1547 (01)00801741106552(17)230917(10)ANFW2016 (01)00801741106552(17)230924(10)ANFW3148 (01)00801741106552(17)231001(10)ANFX0112 (01)00801741106552(17)231012(10)ANFX1798 (01)00801741106552(17)231015(10)ANFX2273 (01)00801741106552(17)231105(10)ANFY0620 (01)00801741106552(17)231112(10)ANFY1675 ANFT0487 ANFT1475 ANFT2597 ANFT3760 ANFU0161 ANFU1106 ANFU2985 ANFU3452 ANFU3901 ANFV0842 ANFV1547 ANFW2016 ANFW3148 ANFX0112 ANFX1798 ANFX2273 ANFY0620 ANFY1675 AVFM09080 (01)00801741106569(17)230604(10)ANFT0471 (01)00801741106569(17)230611(10)ANFT1476 (01)00801741106569(17)230618(10)ANFT2598 (01)00801741106569(17)230625(10)ANFT3587 (01)00801741106569(17)230713(10)ANFU1517 (01)00801741106569(17)230716(10)ANFU2245 (01)00801741106569(17)230723(10)ANFU2986 (01)00801741106569(17)230809(10)ANFV0843 (01)00801741106569(17)230820(10)ANFV1931 (01)00801741106569(17)230823(10)ANFV2292 (01)00801741106569(17)230827(10)ANFV2576 (01)00801741106569(17)230903(10)ANFW0162 ANFT0471 ANFT1476 ANFT2598 ANFT3587 ANFU1517 ANFU2245 ANFU2986 ANFV0843 ANFV1931 ANFV2292 ANFV2576 ANFW0162 AVFM09100 (01)00801741106576(17)230618(10)ANFT2599 (01)00801741106576(17)230723(10)ANFU2987 (01)00801741106576(17)230804(10)ANFV0171 ANFT2599 ANFU2987 ANFV0171 AVFM10040 (01)00801741106583(17)230625(10)ANFT3620 (01)00801741106583(17)230723(10)ANFU3107 (01)00801741106583(17)230806(10)ANFV0343 (01)00801741106583(17)230827(10)ANFV2606 (01)00801741106583(17)230903(10)ANFW0163 (01)00801741106583(17)230910(10)ANFW1461 (01)00801741106583(17)230924(10)ANFW3149 (01)00801741106583(17)231008(10)ANFX1458 (01)00801741106583(17)231022(10)ANFX3164 ANFT3620 ANFU3107 ANFV0343 ANFV2606 ANFW0163 ANFW1461 ANFW3149 ANFX1458 ANFX3164 AVFM10060 (01)00801741106590(17)230604(10)ANFT0453 (01)00801741106590(17)230604(10)ANFT0481 (01)00801741106590(17)230611(10)ANFT1477 (01)00801741106590(17)230618(10)ANFT2600 (01)00801741106590(17)230625(10)ANFT3621 (01)00801741106590(17)230702(10)ANFU0187 (01)00801741106590(17)230716(10)ANFU2246 (01)00801741106590(17)230716(10)ANFU2271 (01)00801741106590(17)230723(10)ANFU2989 (01)00801741106590(17)230728(10)ANFU3606 (01)00801741106590(17)230813(10)ANFV1043 (01)00801741106590(17)230827(10)ANFV2577 (01)00801741106590(17)230903(10)ANFW0190 (01)00801741106590(17)230910(10)ANFW1462 (01)00801741106590(17)230917(10)ANFW2017 (01)00801741106590(17)230924(10)ANFW3150 (01)00801741106590(17)231015(10)ANFX2039 (01)00801741106590(17)231015(10)ANFX2266 (01)00801741106590(17)231028(10)ANFX3741 (01)00801741106590(17)231112(10)ANFY1676 ANFT0453 ANFT0481 ANFT1477 ANFT2600 ANFT3621 ANFU0187 ANFU2246 ANFU2271 ANFU2989 ANFU3606 ANFV1043 ANFV2577 ANFW0190 ANFW1462 ANFW2017 ANFW3150 ANFX2039 ANFX2266 ANFX3741 ANFY1676 AVFM10080 (01)00801741106606(17)230604(10)ANFT0468 (01)00801741106606(17)230611(10)ANFT1478 (01)00801741106606(17)230702(10)ANFU0162 (01)00801741106606(17)230716(10)ANFU2247 (01)00801741106606(17)230723(10)ANFU2990 (01)00801741106606(17)230813(10)ANFV1044 (01)00801741106606(17)230910(10)ANFW1486 (01)00801741106606(17)230917(10)ANFW2018 (01)00801741106606(17)230924(10)ANFW3151 (01)00801741106606(17)231022(10)ANFX3126 (01)00801741106606(17)231029(10)ANFX4100 (01)00801741106606(17)231101(10)ANFY0008 ANFT0468 ANFT1478 ANFU0162 ANFU2247 ANFU2990 ANFV1044 ANFW1486 ANFW2018 ANFW3151 ANFX3126 ANFX4100 ANFY0008 AVFM10100 (01)00801741106613(17)230611(10)ANFT1479 (01)00801741106613(17)230716(10)ANFU2248 (01)00801741106613(17)230917(10)ANFW2019 (01)00801741106613(17)230924(10)ANFW3152 (01)00801741106613(17)231022(10)ANFX3165 (01)00801741106613(17)231105(10)ANFY0657 (01)00801741106613(17)231216(10)ANFZ1833 ANFT1479 ANFU2248 ANFW2019 ANFW3152 ANFX3165 ANFY0657 ANFZ1833 AVSL06040 (01)00801741106637(17)230611(10)ANFT1489 (01)00801741106637(17)230924(10)ANFW3154 ANFT1489 ANFW3154 AVSL06060 (01)00801741106644(17)230903(10)ANFW0192 (01)00801741106644(17)231105(10)ANFY0662 ANFW0192 ANFY0662 AVSL06080 (01)00801741106651(17)230625(10)ANFT3590 ANFT3590 AVSL06100 (01)00801741106668(17)230806(10)ANFV0344 (01)00801741106668(17)231105(10)ANFY0663 ANFV0344 ANFY0663 AVSL07040 (01)00801741106682(17)230604(10)ANFT0475 (01)00801741106682(17)230917(10)ANFW2174 ANFT0475 ANFW2174 AVSL07060 (01)00801741106699(17)230611(10)ANFT1490 (01)00801741106699(17)230730(10)ANFU4194 (01)00801741106699(17)230806(10)ANFV0316 (01)00801741106699(17)230917(10)ANFW2021 ANFT1490 ANFU4194 ANFV0316 ANFW2021 AVSL07080 (01)00801741106705(17)230813(10)ANFV1066 (01)00801741106705(17)230903(10)ANFW0199 ANFV1066 ANFW0199 AVSL07100 (01)00801741106712(17)230721(10)ANFU2534 (01)00801741106712(17)231105(10)ANFY0664 ANFU2534 ANFY0664 AVSL08040 (01)00801741106736(17)230806(10)ANFV0315 ANFV0315 AVSL08060 (01)00801741106743(17)230820(10)ANFV1952 (01)00801741106743(17)230827(10)ANFV2608 (01)00801741106743(17)230903(10)ANFW0193 (01)00801741106743(17)230924(10)ANFW3155 ANFV1952 ANFV2608 ANFW0193 ANFW3155 AVSL08080 (01)00801741106750(17)230625(10)ANFT3591 (01)00801741106750(17)231022(10)ANFX3167 ANFT3591 ANFX3167 AVSL08100 (01)00801741106767(17)230924(10)ANFW3156 (01)00801741106767(17)231112(10)ANFY1680 ANFW3156 ANFY1680 AVSL09040 (01)00801741106781(17)230924(10)ANFW3157 ANFW3157 AVSL09060 (01)00801741106798(17)230702(10)ANFU0166 (01)00801741106798(17)230903(10)ANFW0200 ANFU0166 ANFW0200 AVSL09080 (01)00801741106804(17)231112(10)ANFY1681 ANFY1681 AVSL09100 (01)00801741106811(17)230709(10)ANFU1080 (01)00801741106811(17)230924(10)ANFW3159 ANFU1080 ANFW3159 AVSL10040 (01)00801741106835(17)230806(10)ANFV0324 ANFV0324 AVSL10080 (01)00801741106859(17)230806(10)ANFV0334 (01)00801741106859(17)231105(10)ANFY0621 ANFV0334 ANFY0621 AVSL10100 (01)00801741106866(17)231022(10)ANFX3163 ANFX3163 AVSM06030 (01)00801741106170(17)230827(10)ANFV2609 (01)00801741106170(17)230924(10)ANFW3160 ANFV2609 ANFW3160 AVSM06040 (01)00801741106187(17)230604(10)ANFT0455 (01)00801741106187(17)230611(10)ANFT1491 (01)00801741106187(17)230714(10)ANFU1731 (01)00801741106187(17)230716(10)ANFU2251 (01)00801741106187(17)230903(10)ANFW0194 (01)00801741106187(17)230910(10)ANFW1465 (01)00801741106187(17)230917(10)ANFW2022 (01)00801741106187(17)230924(10)ANFW3161 (01)00801741106187(17)231015(10)ANFX2275 (01)00801741106187(17)231105(10)ANFY0622 ANFT0455 ANFT1491 ANFU1731 ANFU2251 ANFW0194 ANFW1465 ANFW2022 ANFW3161 ANFX2275 ANFY0622 AVSM06060 (01)00801741106194(17)230604(10)ANFT0493 (01)00801741106194(17)230709(10)ANFU1076 (01)00801741106194(17)230806(10)ANFV0345 (01)00801741106194(17)230903(10)ANFW0195 (01)00801741106194(17)230910(10)ANFW1466 (01)00801741106194(17)230917(10)ANFW2023 (01)00801741106194(17)230924(10)ANFW3162 (01)... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, WI, and WV the country of Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 15, 2023
- Recall initiation date
- Dec 22, 2022
- Center classification date
- Feb 9, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.