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Bard Peripheral Vascular Inc recalls The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol
Recalled February 15, 2023 · FDA recall Z-1108-2023 · Bard Peripheral Vascular
Hazard
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding. · FDA Class II
Units
10,815 devices (U.S. total)
Sold at
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.
Description
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
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.
Manufacturer(s)
Bard Peripheral Vascular Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →