Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fusion Bioline Vascular Graft Recalled by Maquet Cardiovascular, LLC Due to One (1) Fusion Bioline Vascular graft from lot...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Cardiovascular, LLC directly.
Affected Products
Fusion Bioline Vascular Graft, Part number M00201503046B0
Quantity: 1 (US)
Why Was This Recalled?
One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Cardiovascular, LLC
Maquet Cardiovascular, LLC has 251 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report