# FDA recall Z-1282-2022

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2022-04-29.

## Product

INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta

## Reason for recall

Mislabeled: Product  labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm

## Distribution

US Nationwide distribution in the state of SC.

## Key facts

- **Recall number:** Z-1282-2022
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-04-29
- **Report date:** 2022-06-29
- **Termination date:** 2024-04-18

- **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-1282-2022

## Citation

> AI Analytics. FDA recall Z-1282-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1282-2022. Source: US FDA. Licensed CC0.

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