Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk
Maquet Cardiovascular is recalling specific 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 risk of intra-operative bleeding, which is a risk-of-harm product where specific injury counts are not reported in the source text, fitting the 'High' severity criteria.
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 defect where potential small holes may exist at the seam lines of the graft branches. This defect can 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 serial numbers 1174771828, 1174771106, and 1174769941. The product was distributed worldwide, including the United States, Canada, and various countries in Europe, Asia, and South America.
Healthcare providers and facilities that have received these specific serial numbers should stop using the affected grafts and contact Maquet Cardiovascular for instructions on return or replacement. Patients who have had these specific grafts implanted should contact their healthcare provider to discuss the recall and any necessary follow-up care.
The recalled product
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - 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: 1174771828 1174771106 1174769941
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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