CLASS II ONGOING Device recall · Reported 22 Mar 2023 · FDA Enforcement Report
Fusion Bioline Vascular Graft recalled by Maquet Cardiovascular
Maquet Cardiovascular is recalling Fusion Bioline Vascular Graft, distributed nationwide in the US. The recall was initiated on 30 Jan 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1245-2023
- FDA event ID
- 91671
- Recalling firm
- Maquet Cardiovascular, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jan 2023
- FDA classified
- 10 Mar 2023
- Reported
- 22 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 30 Jan 2023 | Recall initiated by company | |
| 10 Mar 2023 | Classified by FDA | +39 days |
| 22 Mar 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Fusion Bioline Vascular Graft, Part number M00201503046B0
Where it was distributed
US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
Nationwide FloridaIndianaLouisianaMichiganMissouriNorth CarolinaNevadaNew YorkPennsylvaniaTennesseeTexasVirginiaWashington
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI 00384409005942 Lot 25162546
Where was it sold?
US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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