FDA-Device2023-02-15Class II
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.
Bard Peripheral Vascular Inc
Hazard
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
Sold states
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.
Affected count
10,815 devices (U.S. total)
Manufactured in
1625 W 3rd St Bldg 1, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1108-2023Don't want to check this manually?
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