Maquet Hemashield Vascular Grafts Recalled for Potential Seam Line Holes
Maquet Cardiovascular is recalling specific Hemashield Gold vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, fitting the High severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific units of the Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral. The recall is issued because of potential small holes at the seam lines of the graft branches, which may 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 includes specific serial numbers: 1175589583, 1175603872, 1175612382, 1179652954, and 1179653616. The product was distributed worldwide, including in the United States and various international markets.
Healthcare providers and facilities should check their inventory for these specific serial numbers and stop using the affected devices. Patients who have had these grafts implanted should contact their healthcare provider for further instructions.
The recalled product
- Product
- Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - 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: 1175589583 1175603872 1175612382 1179652954 1179653616
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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