Bard Peripheral Vascular Inc: 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 s

Hazard

An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

Details from the source

Reason for recall: An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding. 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. Quantity: 10,815 devices (U.S. total) Lot/code info: 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 (0

UPC codes

00801741106422, 00801741106446, 00801741106453, 00801741106460, 00801741106477, 00801741106484, 00801741106491, 00801741106507, 00801741106514, 00801741106521, 00801741106538, 00801741106545, 00801741106552, 00801741106569, 00801741106576, 00801741106583, 00801741106590, 00801741106606, 00801741106613, 00801741106637, 00801741106644, 00801741106651, 00801741106668, 00801741106682, 00801741106699, 00801741106705, 00801741106712, 00801741106736, 00801741106743, 00801741106750, 00801741106767, 00801741106781, 00801741106798, 00801741106804, 00801741106811, 00801741106835, 00801741106859, 00801741106866, 00801741106170, 00801741106187

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.