Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling Hemashield Gold Knitted Microvel Double Velour Vascular Grafts due to potential small holes at the 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 involves a risk-of-harm medical device (potential intra-operative bleeding) where specific injury or illness counts are not reported in the source text, fitting the High severity criteria for theoretical or unreported harm risks.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Hemashield Gold Knitted Microvel Double Velour Vascular Grafts, specifically the Axillo-bifemoral configuration (Product Code: M002020955880). These medical devices are used for the replacement or repair of arteries affected with aneurysmal or occlusive disease.
The recall is issued because of potential small holes at the seam lines of the Hemashield branches. These defects may cause intra-operative bleeding at the seam lines of the branches during surgical procedures.
The affected products were distributed worldwide, including in the United States and numerous international markets such as Canada, the UK, Germany, and Japan. Specific serial numbers are listed in the official recall documentation. Healthcare providers and patients should contact Maquet Cardiovascular or their local FDA office for further instructions on handling these devices.
The recalled product
- Product
- Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - 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
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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