Fusion Bioline Vascular Graft, Part number M00201503046B0
FDA Recall Z-1245-2023 · Posted 2023-03-10
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Recalling FirmMaquet Cardiovascular, LLC
Recall StatusOpen, Classified
Product CodeDSY
Date Initiated2023-01-30
Product Quantity1 (US)
Reason for Recall
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.
Firm Action
On January 30, 2023, the firm notified customers via Urgent Medical Device Removal letters.
Customers are asked to examine your inventory immediately for lot 25162546.
Please note, the Lot number appears on the device shelf boxes only.
If you have the affected lot, please stop using and remove the device from areas of use. You are entitled to a replacement at no cost to your facility. You will receive replacement upon your acknowledgement that you have product for return.
Distributors who have shipped this product should notify their customers.
Please contact Getinge Customer Service at 888-943-8872 between the hours of 8:00 a.m. and 6:00 p.m. Eastern
Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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