Z-1245-2023Class II

Fusion Bioline Vascular Graft, Part number M00201503046B0

Name: Z-1245-2023 Fusion Bioline Vascular Graft, Part number M00201503046B0
Creator: Maquet Cardiovascular, LLC
Published: 2023-01-30
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2023-01-30 / Open, Classified / root cause: manufacturing process

FDA source

Maquet Cardiovascular, LLC began a recall of Fusion Bioline Vascular Graft, Part number M00201503046B0 on 2023-01-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1245-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-30
Posted: 2023-03-10
Recalling firm: Maquet Cardiovascular LLC
Product: Fusion Bioline Vascular Graft, Part number M00201503046B0
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 1 (US)
Distribution: US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
Product codes and lots: UDI-DI 00384409005942 Lot 25162546

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1245-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1245-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10

Product code DSY

K131778Class IIFusion Vascular Graft and Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC / cleared 2013-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)