—#198468

Product

Fusion Bioline Vascular Graft, Part number M00201503046B0

FDA product code: DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K131778
Affected lot / code info: UDI-DI 00384409005942 Lot 25162546

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.

Timeline

Recall initiated: 2023-01-30
Posted by FDA: 2023-03-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198468. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.