Fusion Bioline Vascular Graft, Part number M00201503046B0 recallZ-1245-2023 · Maquet Cardiovascular, LLC · initiated Jan 30, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1245-2023
- Status
- Open, Classified
- Initiated by the company
- Jan 30, 2023
- Posted by the FDA
- Mar 10, 2023
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 1 (US)
- Product code
- DSY
- FDA submissions
- K131778
- Distribution
- US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
Product description
Fusion Bioline Vascular Graft, Part number M00201503046B0
Code information (models, lots, serial numbers)
UDI-DI 00384409005942 Lot 25162546
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Fusion Bioline Supported Vascular Grafts M00201503046B0Maquet Cardiovascular LLC · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall0 reports
Other devices under the same FDA submission
4 devices cleared under K131778 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Fusion Vascular Grafts M002015010470Maquet Cardiovascular LLC · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Fusion Supported Vascular Grafts M002015030460Maquet Cardiovascular LLC · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Fusion Supported Vascular Grafts M002015030680Maquet Cardiovascular LLC · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
- Fusion Supported Vascular Grafts M002015030870Maquet Cardiovascular LLC · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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