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.
Reported: February 15, 2023 Initiated: December 22, 2022 #Z-1108-2023
Product Description
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 for Recall
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
Details
- Recalling Firm
- Bard Peripheral Vascular Inc
- Units Affected
- 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.
- Location
- Tempe, AZ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bard Peripheral Vascular Inc. Units affected: 10,815 devices (U.S. total).
Why was this product recalled? ▼
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2023. Severity: Moderate. Recall number: Z-1108-2023.
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