# FDA recall Z-1108-2023

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2022-12-22.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1108-2023
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-22
- **Report date:** 2023-02-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1108-2023

## Citation

> AI Analytics. FDA recall Z-1108-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1108-2023. Source: US FDA. Licensed CC0.

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