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 high-risk medical device where a defect could cause injury (bleeding) during surgery, but no specific injuries or illnesses are reported in the source text, fitting the 'High' 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 issued because of potential small holes at the seam lines of the graft branches. These defects could cause intra-operative bleeding 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 with specific serial numbers listed in the agency documentation. The product was distributed worldwide, including in the United States and various international locations such as Canada, the UK, and Germany.
Healthcare providers and patients should contact Maquet Cardiovascular for further instructions regarding the return or replacement of these devices. The recall is classified as Class II by the FDA, 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 Graft-4 Branch, Product Code: M00202175926P0 - 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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