Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at the 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 is classified as FDA Class II and involves a risk of intra-operative bleeding, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific units of the HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch. The recall is due to a potential defect where small holes may exist at the seam lines of the graft branches. This defect could result in 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 includes specific serial numbers listed in the agency documentation. The product was distributed worldwide, including in the United States and various international markets such as Canada, Japan, and several European countries.
Healthcare providers and patients should contact Maquet Cardiovascular for further instructions regarding the return or replacement of these devices. The FDA has classified this as a Class II recall, indicating that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - 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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