# FDA recall Z-1245-2023

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2023-01-30.

## Product

Fusion Bioline Vascular Graft, Part number M00201503046B0

## Reason for recall

One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.

## Distribution

US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.

## Key facts

- **Recall number:** Z-1245-2023
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-30
- **Report date:** 2023-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1245-2023

## Citation

> AI Analytics. FDA recall Z-1245-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1245-2023. Source: US FDA. Licensed CC0.

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