| | Class 2 Device Recall Covera Vascular Covered Stent |  |
| Date Initiated by Firm | December 22, 2022 |
|---|
| Date Posted | February 09, 2023 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1108-2023 |
|---|
| Recall Event ID |
91359 |
| Product Classification |
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment - Product Code PFV
|
| 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. |
|---|
| Code Information |
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)00801741106194(17)231001(10)ANFX0091
(01)00801741106194(17)231015(10)ANFX2276
(01)00801741106194(17)231029(10)ANFX4104
(01)00801741106194(17)231105(10)ANFY0666
ANFT0493
ANFU1076
ANFV0345
ANFW0195
ANFW1466
ANFW2023
ANFW3162
ANFX0091
ANFX2276
ANFX4104
ANFY0666
AVSM06080
(01)00801741106200(17)230827(10)ANFV2610
(01)00801741106200(17)230903(10)ANFW0196
(01)00801741106200(17)230924(10)ANFW3163
(01)00801741106200(17)231015(10)ANFX2277
(01)00801741106200(17)231105(10)ANFY0623
(01)00801741106200(17)231112(10)ANFY1682
ANFV2610
ANFW0196
ANFW3163
ANFX2277
ANFY0623
ANFY1682
AVSM06100
(01)00801741106217(17)230618(10)ANFT2601
(01)00801741106217(17)230924(10)ANFW3164
ANFT2601
ANFW3164
AVSM07030
(01)00801741106224(17)230917(10)ANFW2024
(01)00801741106224(17)230924(10)ANFW3165
(01)00801741106224(17)231029(10)ANFX4137
ANFW2024
ANFW3165
ANFX4137
AVSM07040
(01)00801741106231(17)230604(10)ANFT0476
(01)00801741106231(17)230611(10)ANFT1493
(01)00801741106231(17)230618(10)ANFT2602
(01)00801741106231(17)230709(10)ANFU1077
(01)00801741106231(17)230716(10)ANFU2252
(01)00801741106231(17)230723(10)ANFU2991
(01)00801741106231(17)230730(10)ANFU4088
(01)00801741106231(17)230806(10)ANFV0355
(01)00801741106231(17)230813(10)ANFV1045
(01)00801741106231(17)230827(10)ANFV2578
(01)00801741106231(17)230903(10)ANFW0164
(01)00801741106231(17)230917(10)ANFW2025
(01)00801741106231(17)230924(10)ANFW3166
(01)00801741106231(17)231001(10)ANFX0101
(01)00801741106231(17)231015(10)ANFX2278
(01)00801741106231(17)231022(10)ANFX3173
(01)00801741106231(17)231029(10)ANFX4105
(01)00801741106231(17)231105(10)ANFY0668
(01)00801741106231(17)231112(10)ANFY1683
(01)00801741106231(17)231215(10)ANFZ1828
ANFT0476
ANFT1493
ANFT2602
ANFU1077
ANFU2252
ANFU2991
ANFU4088
ANFV0355
ANFV1045
ANFV2578
ANFW0164
ANFW2025
ANFW3166
ANFX0101
ANFX2278
ANFX3173
ANFX4105
ANFY0668
ANFY1683
ANFZ1828
AVSM07060
(01)00801741106248(17)230604(10)ANFT0456
(01)00801741106248(17)230611(10)ANFT1492
(01)00801741106248(17)230618(10)ANFT2603
(01)00801741106248(17)230709(10)ANFU1078
(01)00801741106248(17)230713(10)ANFU1518
(01)00801741106248(17)230716(10)ANFU2253
(01)00801741106248(17)230723(10)ANFU2992
(01)00801741106248(17)230813(10)ANFV1061
(01)00801741106248(17)230827(10)ANFV2612
(01)00801741106248(17)230903(10)ANFW0165
(01)00801741106248(17)230903(10)ANFW0183
(01)00801741106248(17)230910(10)ANFW1467
(01)00801741106248(17)230917(10)ANFW2026
(01)00801741106248(17)230924(10)ANFW3167
(01)00801741106248(17)231015(10)ANFX2038
(01)00801741106248(17)231015(10)ANFX2270
(01)00801741106248(17)231026(10)ANFX3589
(01)00801741106248(17)231029(10)ANFX4106
(01)00801741106248(17)231112(10)ANFY1684
ANFT0456
ANFT1492
ANFT2603
ANFU1078
ANFU1518
ANFU2253
ANFU2992
ANFV1061
ANFV2612
ANFW0165
ANFW0183
ANFW1467
ANFW2026
ANFW3167
ANFX2038
ANFX2270
ANFX3589
ANFX4106
ANFY1684
AVSM07080
(01)00801741106255(17)230604(10)ANFT0457
(01)00801741106255(17)230618(10)ANFT2604
(01)00801741106255(17)230714(10)ANFU1729
(01)00801741106255(17)230716(10)ANFU2275
(01)00801741106255(17)230723(10)ANFU2993
(01)00801741106255(17)230903(10)ANFW0166
(01)00801741106255(17)230910(10)ANFW1468
(01)00801741106255(17)230924(10)ANFW3168
(01)00801741106255(17)231001(10)ANFX0113
(01)00801741106255(17)231015(10)ANFX2229
(01)00801741106255(17)231029(10)ANFX4139
(01)00801741106255(17)231105(10)ANFY0624
(01)00801741106255(17)231112(10)ANFY1685
(01)00801741106255(17)231112(10)ANFY1832
ANFT0457
ANFT2604
ANFU1729
ANFU2275
ANFU2993
ANFW0166
ANFW1468
ANFW3168
ANFX0113
ANFX2229
ANFX4139
ANFY0624
ANFY1685
ANFY1832
AVSM07100
(01)00801741106262(17)230604(10)ANFT0458
(01)00801741106262(17)230618(10)ANFT2605
(01)00801741106262(17)230713(10)ANFU1516
(01)00801741106262(17)230716(10)ANFU2255
(01)00801741106262(17)230727(10)ANFU3322
(01)00801741106262(17)230823(10)ANFV2293
(01)00801741106262(17)230827(10)ANFV2579
(01)00801741106262(17)230917(10)ANFW2027
(01)00801741106262(17)231007(10)ANFX1079
(01)00801741106262(17)231028(10)ANFX3739
ANFT0458
ANFT2605
ANFU1516
ANFU2255
ANFU3322
ANFV2293
ANFV2579
ANFW2027
ANFX1079
ANFX3739
AVSM08030
(01)00801741106279(17)230723(10)ANFU3006
(01)00801741106279(17)230730(10)ANFU4089
(01)00801741106279(17)230820(10)ANFV1935
(01)00801741106279(17)230903(10)ANFW0167
(01)00801741106279(17)231001(10)ANFX0076
(01)00801741106279(17)231105(10)ANFY0667
ANFU3006
ANFU4089
ANFV1935
ANFW0167
ANFX0076
ANFY0667
AVSM08040
(01)00801741106286(17)230604(10)ANFT0459
(01)00801741106286(17)230618(10)ANFT2616
(01)00801741106286(17)230618(10)ANFT2626
(01)00801741106286(17)230705(10)ANFU0489
(01)00801741106286(17)230723(10)ANFU2994
(01)00801741106286(17)230730(10)ANFU4090
(01)00801741106286(17)230806(10)ANFV0325
(01)00801741106286(17)230813(10)ANFV1052
(01)00801741106286(17)230813(10)ANFV1062
(01)00801741106286(17)230813(10)ANFV1068
(01)00801741106286(17)230820(10)ANFV1936
(01)00801741106286(17)230827(10)ANFV2580
(01)00801741106286(17)230903(10)ANFW0168
(01)00801741106286(17)230910(10)ANFW1469
(01)00801741106286(17)230917(10)ANFW2028
(01)00801741106286(17)230924(10)ANFW3158
(01)00801741106286(17)231001(10)ANFX0077
(01)00801741106286(17)231001(10)ANFX0107
(01)00801741106286(17)231008(10)ANFX1419
(01)00801741106286(17)231015(10)ANFX2230
(01)00801741106286(17)231022(10)ANFX2965
(01)00801741106286(17)231022(10)ANFX3174
(01)00801741106286(17)231105(10)ANFY0614
(01)00801741106286(17)231105(10)ANFY0625
(01)00801741106286(17)231112(10)ANFY1671
(01)00801741106286(17)231112(10)ANFY1686
ANFT0459
ANFT2616
ANFT2626
ANFU0489
ANFU2994
ANFU4090
ANFV0325
ANFV1052
ANFV1062
ANFV1068
ANFV1936
ANFV2580
ANFW0168
ANFW1469
ANFW2028
ANFW3158
ANFX0077
ANFX0107
ANFX1419
ANFX2230
ANFX2965
ANFX3174
ANFY0614
ANFY0625
ANFY1671
ANFY1686
AVSM08060
(01)00801741106293(17)230528(10)ANFS4997
(01)00801741106293(17)230604(10)ANFT0477
(01)00801741106293(17)230611(10)ANFT1488
(01)00801741106293(17)230611(10)ANFT1528
(01)00801741106293(17)230618(10)ANFT2606
(01)00801741106293(17)230618(10)ANFT2634
(01)00801741106293(17)230709(10)ANFU1104
(01)00801741106293(17)230716(10)ANFU2254
(01)00801741106293(17)230716(10)ANFU2265
(01)00801741106293(17)230723(10)ANFU2995
(01)00801741106293(17)230730(10)ANFU4091
(01)00801741106293(17)230806(10)ANFV0317
(01)00801741106293(17)230806(10)ANFV0326
(01)00801741106293(17)230806(10)ANFV0335
(01)00801741106293(17)230806(10)ANFV0346
(01)00801741106293(17)230806(10)ANFV0356
(01)00801741106293(17)230813(10)ANFV1063
(01)00801741106293(17)230813(10)ANFV1073
(01)00801741106293(17)230820(10)ANFV1930
(01)00801741106293(17)230820(10)ANFV1942
(01)00801741106293(17)230820(10)ANFV1951
(01)00801741106293(17)230827(10)ANFV2581
(01)00801741106293(17)230827(10)ANFV2597
(01)00801741106293(17)230827(10)ANFV2611
(01)00801741106293(17)230903(10)ANFW0169
(01)00801741106293(17)230903(10)ANFW0191
(01)00801741106293(17)230910(10)ANFW1470
(01)00801741106293(17)230910(10)ANFW1488
(01)00801741106293(17)230917(10)ANFW2058
(01)00801741106293(17)230924(10)ANFW3169
(01)00801741106293(17)231001(10)ANFX0084
(01)00801741106293(17)231001(10)ANFX0085
(01)00801741106293(17)231001(10)ANFX0092
(01)00801741106293(17)231008(10)ANFX1420
(01)00801741106293(17)231008(10)ANFX1439
(01)00801741106293(17)231015(10)ANFX2231
(01)00801741106293(17)231015(10)ANFX2258
(01)00801741106293(17)231022(10)ANFX3129
(01)00801741106293(17)231022(10)ANFX3162
(01)00801741106293(17)231105(10)ANFY0626
(01)00801741106293(17)231105(10)ANFY0640
(01)00801741106293(17)231105(10)ANFY0659
(01)00801741106293(17)231112(10)ANFY1687
(01)00801741106293(17)231112(10)ANFY1718
(01)00801741106293(17)231116(10)ANFY2290
(01)00801741106293(17)231118(10)ANFY2512
ANFS4997
ANFT0477
ANFT1488
ANFT1528
ANFT2606
ANFT2634
ANFU1104
ANFU2254
ANFU2265
ANFU2995
ANFU4091
ANFV0317
ANFV0326
ANFV0335
ANFV0346
ANFV0356
ANFV1063
ANFV1073
ANFV1930
ANFV1942
ANFV1951
ANFV2581
ANFV2597
ANFV2611
ANFW0169
ANFW0191
ANFW1470
ANFW1488
ANFW2058
ANFW3169
ANFX0084
ANFX0085
ANFX0092
ANFX1420
ANFX1439
ANFX2231
ANFX2258
ANFX3129
ANFX3162
ANFY0626
ANFY0640
ANFY0659
ANFY1687
ANFY1718
ANFY2290
ANFY2512
AVSM08080
(01)00801741106309(17)230604(10)ANFT0460
(01)00801741106309(17)230604(10)ANFT0473
(01)00801741106309(17)230611(10)ANFT1494
(01)00801741106309(17)230618(10)ANFT2607
(01)00801741106309(17)230702(10)ANFU0167
(01)00801741106309(17)230709(10)ANFU1079
(01)00801741106309(17)230730(10)ANFU4092
(01)00801741106309(17)230813(10)ANFV1046
(01)00801741106309(17)230813(10)ANFV1069
(01)00801741106309(17)230813(10)ANFV1074
(01)00801741106309(17)230820(10)ANFV1937
(01)00801741106309(17)230820(10)ANFV1943
(01)00801741106309(17)230827(10)ANFV2582
(01)00801741106309(17)230903(10)ANFW0171
(01)00801741106309(17)230910(10)ANFW1471
(01)00801741106309(17)230910(10)ANFW1491
(01)00801741106309(17)230917(10)ANFW2029
(01)00801741106309(17)230924(10)ANFW3170
(01)00801741106309(17)231001(10)ANFX0093
(01)00801741106309(17)231001(10)ANFX0102
(01)00801741106309(17)231008(10)ANFX1454
(01)00801741106309(17)231015(10)ANFX2232
(01)00801741106309(17)231022(10)ANFX2966
(01)00801741106309(17)231022(10)ANFX3175
(01)00801741106309(17)231029(10)ANFX4107
(01)00801741106309(17)231029(10)ANFX4136
(01)00801741106309(17)231101(10)ANFY0001
(01)00801741106309(17)231105(10)ANFY0669
ANFT0460
ANFT0473
ANFT1494
ANFT2607
ANFU0167
ANFU1079
ANFU4092
ANFV1046
ANFV1069
ANFV1074
ANFV1937
ANFV1943
ANFV2582
ANFW0171
ANFW1471
ANFW1491
ANFW2029
ANFW3170
ANFX0093
ANFX0102
ANFX1454
ANFX2232
ANFX2966
ANFX3175
ANFX4107
ANFX4136
ANFY0001
ANFY0669
AVSM08100
(01)00801741106316(17)230604(10)ANFT0461
(01)00801741106316(17)230611(10)ANFT1495
(01)00801741106316(17)230618(10)ANFT2608
(01)00801741106316(17)230709(10)ANFU1081
(01)00801741106316(17)230714(10)ANFU1730
(01)00801741106316(17)230716(10)ANFU2256
(01)00801741106316(17)230723(10)ANFU2996
(01)00801741106316(17)230813(10)ANFV1075
(01)00801741106316(17)230827(10)ANFV2583
(01)00801741106316(17)230903(10)ANFW0201
(01)00801741106316(17)230910(10)ANFW1472
(01)00801741106316(17)230917(10)ANFW2052
(01)00801741106316(17)230924(10)ANFW3171
(01)00801741106316(17)231001(10)ANFX0078
(01)00801741106316(17)231008(10)ANFX1421
(01)00801741106316(17)231015(10)ANFX2233
(01)00801741106316(17)231022(10)ANFX3130
(01)00801741106316(17)231029(10)ANFX4108
(01)00801741106316(17)231029(10)ANFX4117
(01)00801741106316(17)231112(10)ANFY1688
ANFT0461
ANFT1495
ANFT2608
ANFU1081
ANFU1730
ANFU2256
ANFU2996
ANFV1075
ANFV2583
ANFW0201
ANFW1472
ANFW2052
ANFW3171
ANFX0078
ANFX1421
ANFX2233
ANFX3130
ANFX4108
ANFX4117
ANFY1688
AVSM09030
(01)00801741106323(17)231112(10)ANFY1689
ANFY1689
AVSM09040
(01)00801741106330(17)230604(10)ANFT0462
(01)00801741106330(17)230611(10)ANFT1496
(01)00801741106330(17)230702(10)ANFU0168
(01)00801741106330(17)230709(10)ANFU1082
(01)00801741106330(17)230728(10)ANFU3607
(01)00801741106330(17)230730(10)ANFU4093
(01)00801741106330(17)230813(10)ANFV1076
(01)00801741106330(17)230820(10)ANFV1938
(01)00801741106330(17)230827(10)ANFV2584
(01)00801741106330(17)230903(10)ANFW0172
(01)00801741106330(17)230910(10)ANFW1473
(01)00801741106330(17)230917(10)ANFW2053
(01)00801741106330(17)230924(10)ANFW3172
(01)00801741106330(17)231001(10)ANFX0103
(01)00801741106330(17)231015(10)ANFX2234
(01)00801741106330(17)231022(10)ANFX2967
(01)00801741106330(17)231022(10)ANFX3131
ANFT0462
ANFT1496
ANFU0168
ANFU1082
ANFU3607
ANFU4093
ANFV1076
ANFV1938
ANFV2584
ANFW0172
ANFW1473
ANFW2053
ANFW3172
ANFX0103
ANFX2234
ANFX2967
ANFX3131
AVSM09060
(01)00801741106347(17)230528(10)ANFS5012
(01)00801741106347(17)230604(10)ANFT0479
(01)00801741106347(17)230611(10)ANFT1497
(01)00801741106347(17)230618(10)ANFT2609
(01)00801741106347(17)230709(10)ANFU1083
(01)00801741106347(17)230716(10)ANFU2257
(01)00801741106347(17)230723(10)ANFU2997
(01)00801741106347(17)230728(10)ANFU3608
(01)00801741106347(17)230730(10)ANFU4094
(01)00801741106347(17)230813(10)ANFV1053
(01)00801741106347(17)230820(10)ANFV1939
(01)00801741106347(17)230827(10)ANFV2585
(01)00801741106347(17)230903(10)ANFW0173
(01)00801741106347(17)230903(10)ANFW0188
(01)00801741106347(17)230917(10)ANFW2054
(01)00801741106347(17)230924(10)ANFW3173
(01)00801741106347(17)231001(10)ANFX0108
(01)00801741106347(17)231001(10)ANFX0114
(01)00801741106347(17)231008(10)ANFX1422
(01)00801741106347(17)231015(10)ANFX2236
(01)00801741106347(17)231022(10)ANFX3132
(01)00801741106347(17)231022(10)ANFX3144
(01)00801741106347(17)231105(10)ANFY0627
(01)00801741106347(17)231112(10)ANFY1690
(01)00801741106347(17)231112(10)ANFY1702
(01)00801741106347(17)231119(10)ANFY2817
ANFS5012
ANFT0479
ANFT1497
ANFT2609
ANFU1083
ANFU2257
ANFU2997
ANFU3608
ANFU4094
ANFV1053
ANFV1939
ANFV2585
ANFW0173
ANFW0188
ANFW2054
ANFW3173
ANFX0108
ANFX0114
ANFX1422
ANFX2236
ANFX3132
ANFX3144
ANFY0627
ANFY1690
ANFY1702
ANFY2817
AVSM09080
(01)00801741106354(17)230528(10)ANFS5007
(01)00801741106354(17)230604(10)ANFT0463
(01)00801741106354(17)230611(10)ANFT1498
(01)00801741106354(17)230618(10)ANFT2610
(01)00801741106354(17)230625(10)ANFT3624
(01)00801741106354(17)230702(10)ANFU0169
(01)00801741106354(17)230709(10)ANFU1084
(01)00801741106354(17)230716(10)ANFU2258
(01)00801741106354(17)230723(10)ANFU2998
(01)00801741106354(17)230813(10)ANFV1047
(01)00801741106354(17)230820(10)ANFV1940
(01)00801741106354(17)230827(10)ANFV2586
(01)00801741106354(17)230903(10)ANFW0174
(01)00801741106354(17)230917(10)ANFW2055
(01)00801741106354(17)230924(10)ANFW3174
(01)00801741106354(17)231001(10)ANFX0094
(01)00801741106354(17)231008(10)ANFX1423
(01)00801741106354(17)231015(10)ANFX2237
(01)00801741106354(17)231022(10)ANFX3133
(01)00801741106354(17)231022(10)ANFX3153
(01)00801741106354(17)231105(10)ANFY0628
(01)00801741106354(17)231112(10)ANFY1691
(01)00801741106354(17)231119(10)ANFY2818
ANFS5007
ANFT0463
ANFT1498
ANFT2610
ANFT3624
ANFU0169
ANFU1084
ANFU2258
ANFU2998
ANFV1047
ANFV1940
ANFV2586
ANFW0174
ANFW2055
ANFW3174
ANFX0094
ANFX1423
ANFX2237
ANFX3133
ANFX3153
ANFY0628
ANFY1691
ANFY2818
AVSM09100
(01)00801741106361(17)230528(10)ANFS5008
(01)00801741106361(17)230604(10)ANFT0464
(01)00801741106361(17)230611(10)ANFT1527
(01)00801741106361(17)230618(10)ANFT2611
(01)00801741106361(17)230625(10)ANFT3593
(01)00801741106361(17)230723(10)ANFU2999
(01)00801741106361(17)230820(10)ANFV1941
(01)00801741106361(17)230827(10)ANFV2587
(01)00801741106361(17)230903(10)ANFW0175
(01)00801741106361(17)230910(10)ANFW1474
(01)00801741106361(17)230917(10)ANFW2056
(01)00801741106361(17)231008(10)ANFX1424
(01)00801741106361(17)231015(10)ANFX2239
(01)00801741106361(17)231022(10)ANFX3134
(01)00801741106361(17)231105(10)ANFY0629
ANFS5008
ANFT0464
ANFT1527
ANFT2611
ANFT3593
ANFU2999
ANFV1941
ANFV2587
ANFW0175
ANFW1474
ANFW2056
ANFX1424
ANFX2239
ANFX3134
ANFY0629
AVSM10030
(01)00801741106378(17)231001(10)ANFX0086
ANFX0086
AVSM10040
(01)00801741106385(17)230528(10)ANFS5002
(01)00801741106385(17)230604(10)ANFT0465
(01)00801741106385(17)230618(10)ANFT2612
(01)00801741106385(17)230702(10)ANFU0170
(01)00801741106385(17)230709(10)ANFU1085
(01)00801741106385(17)230716(10)ANFU2259
(01)00801741106385(17)230723(10)ANFU2988
(01)00801741106385(17)230730(10)ANFU4095
(01)00801741106385(17)230820(10)ANFV1933
(01)00801741106385(17)230820(10)ANFV1946
(01)00801741106385(17)230827(10)ANFV2588
(01)00801741106385(17)230903(10)ANFW0176
(01)00801741106385(17)230910(10)ANFW1475
(01)00801741106385(17)230917(10)ANFW2057
(01)00801741106385(17)231001(10)ANFX0079
(01)00801741106385(17)231001(10)ANFX0087
(01)00801741106385(17)231008(10)ANFX1425
(01)00801741106385(17)231015(10)ANFX2241
(01)00801741106385(17)231022(10)ANFX3135
(01)00801741106385(17)231022(10)ANFX3171
(01)00801741106385(17)231029(10)ANFX4140
(01)00801741106385(17)231105(10)ANFY0630
(01)00801741106385(17)231105(10)ANFY0643
(01)00801741106385(17)231112(10)ANFY1693
(01)00801741106385(17)231119(10)ANFY2820
ANFS5002
ANFT0465
ANFT2612
ANFU0170
ANFU1085
ANFU2259
ANFU2988
ANFU4095
ANFV1933
ANFV1946
ANFV2588
ANFW0176
ANFW1475
ANFW2057
ANFX0079
ANFX0087
ANFX1425
ANFX2241
ANFX3135
ANFX3171
ANFX4140
ANFY0630
ANFY0643
ANFY1693
ANFY2820
AVSM10060
(01)00801741106392(17)230604(10)ANFT0478
(01)00801741106392(17)230611(10)ANFT1511
(01)00801741106392(17)230618(10)ANFT2613
(01)00801741106392(17)230702(10)ANFU0171
(01)00801741106392(17)230709(10)ANFU1086
(01)00801741106392(17)230716(10)ANFU2260
(01)00801741106392(17)230723(10)ANFU3000
(01)00801741106392(17)230723(10)ANFU3011
(01)00801741106392(17)230730(10)ANFU4096
(01)00801741106392(17)230820(10)ANFV1944
(01)00801741106392(17)230827(10)ANFV2589
(01)00801741106392(17)230827(10)ANFV2602
(01)00801741106392(17)230903(10)ANFW0177
(01)00801741106392(17)230910(10)ANFW1460
(01)00801741106392(17)230910(10)ANFW1476
(01)00801741106392(17)230910(10)ANFW1502
(01)00801741106392(17)230917(10)ANFW2051
(01)00801741106392(17)231001(10)ANFX0080
(01)00801741106392(17)231001(10)ANFX0088
(01)00801741106392(17)231001(10)ANFX0095
(01)00801741106392(17)231001(10)ANFX0104
(01)00801741106392(17)231008(10)ANFX1426
(01)00801741106392(17)231008(10)ANFX1451
(01)00801741106392(17)231015(10)ANFX2243
(01)00801741106392(17)231022(10)ANFX3136
(01)00801741106392(17)231029(10)ANFX4102
(01)00801741106392(17)231029(10)ANFX4109
(01)00801741106392(17)231029(10)ANFX4130
(01)00801741106392(17)231112(10)ANFY1694
(01)00801741106392(17)231118(10)ANFY2513
(01)00801741106392(17)231119(10)ANFY2857
ANFT0478
ANFT1511
ANFT2613
ANFU0171
ANFU1086
ANFU2260
ANFU3000
ANFU3011
ANFU4096
ANFV1944
ANFV2589
ANFV2602
ANFW0177
ANFW1460
ANFW1476
ANFW1502
ANFW2051
ANFX0080
ANFX0088
ANFX0095
ANFX0104
ANFX1426
ANFX1451
ANFX2243
ANFX3136
ANFX4102
ANFX4109
ANFX4130
ANFY1694
ANFY2513
ANFY2857
AVSM10080
(01)00801741106408(17)230604(10)ANFT0466
(01)00801741106408(17)230611(10)ANFT1499
(01)00801741106408(17)230618(10)ANFT2647
(01)00801741106408(17)230709(10)ANFU1087
(01)00801741106408(17)230716(10)ANFU2261
(01)00801741106408(17)230723(10)ANFU3001
(01)00801741106408(17)230727(10)ANFU3324
(01)00801741106408(17)230806(10)ANFV0336
(01)00801741106408(17)230827(10)ANFV2613
(01)00801741106408(17)230903(10)ANFW0197
(01)00801741106408(17)230910(10)ANFW1477
(01)00801741106408(17)230910(10)ANFW1498
(01)00801741106408(17)230917(10)ANFW2059
(01)00801741106408(17)231001(10)ANFX0096
(01)00801741106408(17)231008(10)ANFX1427
(01)00801741106408(17)231015(10)ANFX2244
(01)00801741106408(17)231029(10)ANFX4111
(01)00801741106408(17)231029(10)ANFX4122
(01)00801741106408(17)231105(10)ANFY0631
(01)00801741106408(17)231112(10)ANFY1695
ANFT0466
ANFT1499
ANFT2647
ANFU1087
ANFU2261
ANFU3001
ANFU3324
ANFV0336
ANFV2613
ANFW0197
ANFW1477
ANFW1498
ANFW2059
ANFX0096
ANFX1427
ANFX2244
ANFX4111
ANFX4122
ANFY0631
ANFY1695
AVSM10100
(01)00801741106415(17)230604(10)ANFT0490
(01)00801741106415(17)230611(10)ANFT1500
(01)00801741106415(17)230618(10)ANFT2614
(01)00801741106415(17)230702(10)ANFU0172
(01)00801741106415(17)230716(10)ANFU2262
(01)00801741106415(17)230723(10)ANFU3002
(01)00801741106415(17)230827(10)ANFV2614
(01)00801741106415(17)230903(10)ANFW0198
(01)00801741106415(17)230910(10)ANFW1478
(01)00801741106415(17)231001(10)ANFX0105
(01)00801741106415(17)231008(10)ANFX1428
(01)00801741106415(17)231015(10)ANFX2245
(01)00801741106415(17)231029(10)ANFX4110
(01)00801741106415(17)231105(10)ANFY0632
(01)00801741106415(17)231112(10)ANFY1696
ANFT0490
ANFT1500
ANFT2614
ANFU0172
ANFU2262
ANFU3002
ANFV2614
ANFW0198
ANFW1478
ANFX0105
ANFX1428
ANFX2245
ANFX4110
ANFY0632
ANFY1696
|
| FEI Number |
2020394
|
Recalling Firm/
Manufacturer |
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
|
| For Additional Information Contact | Padraic OBrien
480-597-8203 |
|---|
Manufacturer Reason
for Recall | An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding. |
|---|
FDA Determined
Cause 2 | Unknown/Undetermined by firm |
|---|
| Action | On 12/22/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx and/or email to customers informing them that BD has identified through customer complaints that the Covera" Vascular Covered Stent has the potential to exhibit deployment issues (i.e., failure to deploy the covered stent) due to slide block bond failures in the device handle.
Customers are instructed to:
1. Discontinue use of product listed in Attachment A, and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process.
2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action.
3. If customers purchased this product from a distributor, contact the distributor for further instructions and replacement, as available, resolution.
4. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not customers have any of the product so that BD may acknowledge receipt of this notification and subsequently process replacements, as available, regarding impacted product.
5. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of.
6. Please contact BD representative if assistance is required with this process or contact the
number below for further assistance:
North American Regional Complaint Center
Phone: 1-844-8BD- LIFE (1-844-823-5433)
Say Recall when prompted
M-F 8am - 5pm CT
Email: productcomplaints@bd.com |
|---|
| Quantity in Commerce | 10,815 devices (U.S. total) |
|---|
| 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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