Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk
Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that may 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-harm product (intra-operative bleeding) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
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 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: 1144930522, 1126647022, and 1158303372. The product was distributed worldwide, including in the United States and various international locations such as Canada, the UK, Germany, and Japan.
Healthcare providers and facilities should check their inventory for the affected serial numbers and stop using these devices. Patients who have had these grafts implanted should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - 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
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 1144930522 1126647022 1158303372
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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