Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Defects
Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that may cause intra-operative bleeding.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of intra-operative bleeding, which is a significant injury risk, but no fatalities or permanent serious injuries are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Hemashield Platinum Woven Double Velour Vascular Grafts, 1 Branch, Product Code M00202175830P0. The recall is due to potential small holes at the seam lines of the graft branches, which may cause intra-operative bleeding during surgical procedures.
The affected products are used for the replacement or repair of arteries affected with aneurysmal or occlusive disease. The recall covers units distributed worldwide, including the United States and various international markets such as Canada, the UK, Germany, and Japan. Specific serial numbers are listed in the agency's recall record.
Healthcare providers and patients should contact Maquet Cardiovascular for instructions on how to manage the recalled devices. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Vascular Graft
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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