Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Defects
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 high-risk medical device where a defect could cause significant injury (intra-operative bleeding), but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific units of the HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch. The recall is due to a defect where potential small holes may exist at the seam lines of the graft branches.
This defect poses a risk of 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 locations. The specific serial numbers affected are listed in the agency's recall record. Healthcare providers and patients should contact Maquet Cardiovascular for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - 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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