Fusion Bioline Vascular Graft recalled due to manufacturing straightness defect
Maquet Cardiovascular is recalling one Fusion Bioline Vascular Graft from lot 25162546 that failed straightness testing. The graft could reduce blood flow or cause tension, potentially leading to bleeding and pseudo-aneurysm.
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: FDA Class II medical device recall for a vascular graft with potential for serious complications including blood flow reduction, bleeding, and pseudo-aneurysm formation. No illnesses or injuries have been reported, qualifying this as a risk-of-harm product without yet-reported injury.
Plain-English summary
Maquet Cardiovascular is recalling one Fusion Bioline Vascular Graft (part number M00201503046B0) from lot 25162546 due to a manufacturing defect. The graft failed guideline straightness testing and was intermingled with product from lot 25162549 before being distributed to customers.
A vascular graft that does not meet straightness specifications poses a risk of reducing blood flow or creating unwanted tension within the vessel. These conditions can lead to serious complications including bleeding and pseudo-aneurysm formation (an abnormal bulge in a blood vessel wall).
The affected graft was distributed nationwide in the states of Florida, Indiana, Louisiana, Michigan, Missouri, North Carolina, Nevada, New York, Pennsylvania, Tennessee, Texas, Virginia, and Washington.
The recalled product
- Product
- Fusion Bioline Vascular Graft, Part number M00201503046B0
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Vascular Graft
- Hazard
- blood-flow-reduction
- pseudo-aneurysm
- bleeding
- device-defect
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)
- UDI-DI 00384409005942 Lot 25162546
Distribution
Distributed nationwide across the United States.
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