Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk
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 involves a medical device with a defect that can cause intra-operative bleeding, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Hemashield Platinum Woven Double Velour Vascular Graft-4 Branch (Product Code: M00202175924P0). The recall is due to a defect where potential small holes may exist at the seam lines of the graft branches. This defect can cause intra-operative bleeding at the seam lines during surgical procedures.
The affected devices are used for the replacement or repair of arteries affected with aneurysmal or occlusive disease. The recall covers specific serial numbers distributed worldwide, including the United States, Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hong Kong, Italy, Korea, Netherlands, Poland, Serbia, and Sweden.
Healthcare providers and patients should contact Maquet Cardiovascular for further instructions regarding the return or replacement of these devices. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - 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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