Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could 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 could cause intra-operative bleeding, a risk-of-harm scenario where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific lots of HEMASHIELD PLATINUM Woven Double Velour Vascular Grafts. The recall is due to a defect where potential small holes may exist at the seam lines of the graft branches. This defect could cause intra-operative bleeding at the seam lines during surgical procedures.
The affected product is 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, Japan, and several European countries. Specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare providers and patients should contact Maquet Cardiovascular or their local distributor for instructions on how to manage the recalled devices. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- 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.
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Vascular Graft
- Hazard
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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