Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular 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 risk of intra-operative bleeding, which is a risk-of-harm product where injury has not yet been reported in the source text, fitting the High severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific units of the HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch. The recall is due to a defect where potential small holes may exist at the seam lines of the graft branches.
The identified hazard is intra-operative bleeding at the seam lines during surgical procedures. The product is used for the replacement or repair of arteries affected with aneurysmal or occlusive disease. The affected units were distributed worldwide, including in the United States and numerous international locations such as Canada, the UK, Germany, and Japan.
Healthcare providers and patients should check their inventory or medical records for the specific serial numbers listed in the official recall notice. If a patient has received one of these grafts, they should contact their healthcare provider for guidance on monitoring or further evaluation. No specific number of affected units or reported injuries is stated in the source text.
The recalled product
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - 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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