# FDA recall Z-2946-2024

> **W L Gore & Associates, Inc.** · Class II · device recall initiated 2024-07-01.

## Product

Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers:    United States:  BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C,  BXB095902C, BXB097902C    *For Clinical use.

## Reason for recall

Due to packaging defects, sterility assurance and heparin activity may be compromised.

## Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, 	CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, 	NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.

## Key facts

- **Recall number:** Z-2946-2024
- **Recalling firm:** W L Gore & Associates, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-01
- **Report date:** 2024-09-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2946-2024

## Citation

> AI Analytics. FDA recall Z-2946-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2946-2024. Source: US FDA. Licensed CC0.

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