Recall Z-1245-2023 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Maquet Cardiovascular, LLC
Fusion Bioline Vascular Graft, Part number M00201503046B0
| Date | Mar 10, 2023 (initiated Jan 30, 2023) |
| Status | Open, Classified |
| Reason | 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 | Process control |
| 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 8 |
| Quantity | 1 (US) |
| Distribution | US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131778 | FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT Maquet Cardiovascular, LLC, Nov 14, 2013 |