# FDA recall Z-1875-2020

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2020-04-07.

## Product

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

## Reason for recall

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil,  Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.

## Key facts

- **Recall number:** Z-1875-2020
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-07
- **Report date:** 2020-05-13
- **Termination date:** 2021-11-05

- **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-1875-2020

## Citation

> AI Analytics. FDA recall Z-1875-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1875-2020. Source: US FDA. Licensed CC0.

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