Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Defects
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may 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 defect that could cause intra-operative bleeding, representing a risk of harm 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 PLATINUM Woven Double Velour Vascular Graft- 1 Branch. The recall is due to potential small holes at the seam lines of the graft branches, which may cause intra-operative bleeding during surgery.
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, Canada, and various countries in Europe, Asia, and South America. Specific serial numbers for the affected units are listed in the agency's official recall record.
Healthcare providers and patients should check their records for the specific serial numbers listed in the recall notice. If a patient has received one of these grafts, they should contact their healthcare provider for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - 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
- Hazard
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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