# FDA recall Z-0729-2022

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2022-01-14.

## Product

HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT-  D: 7 mm; L: 60 cm  Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.      Product Code/REF Number: M002020952070

## Reason for recall

Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm

## Distribution

US Nationwide distribution in the state of MO.

## Key facts

- **Recall number:** Z-0729-2022
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-14
- **Report date:** 2022-03-16
- **Termination date:** 2023-09-19

- **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-0729-2022

## Citation

> AI Analytics. FDA recall Z-0729-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0729-2022. Source: US FDA. Licensed CC0.

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