Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could cause intra-operative bleeding, meeting the criteria for a Severe rating.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Hemashield Platinum Woven Double Velour Vascular Grafts (Thoracoabdominal) due to a defect in the manufacturing process. The recall is issued because potential small holes may exist at the seam lines of the Hemashield branches.
These holes could cause intra-operative bleeding at the seam lines of the branches 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: 1173942817, 1173968078, and 1173846374. 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 patients should contact Maquet Cardiovascular for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - 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: 1173942817 1173968078 1173846374
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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