Fusion Supported Vascular Grafts M002015030680Recalls & reported problems
Maquet Cardiovascular LLC · Fusion 8mm-60cm supp peripheral graft · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384409005737), received between Feb 20, 2021 and Feb 20, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
1 other recall cover devices cleared under the same FDA submission (K131778); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Puncture/Hole1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2021Material Puncture/Hole; Material Puncture/Hole
THE HOSPITAL REPORTED USING FUSION 8MM-60CM SUPP PERIPHERAL GRAFT, HEMORRHAGE FROM APPROX 180 MM FROM THE PROXIMAL SIDE OF FUSION GRAFT. FUSION GRAFT WAS TORN AND CONNECTED ONLY BY THE SUPPORT RING. FUSION GRAFT IMPLANTED IN A BRACHIOCEPHALIC ARTERY TO RIGHT COMMON ILIAC ARTERY BYPASS IN (B)(6) 2018. EXPLANTED FUSION GRAFT AND IMPLANTED GORE-TEX PERIPHERAL VIABAHN STENT GRAFT. FINISHED WITHOUT ANY PROBLEMS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11356022 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131778. One submission often covers many models, so check the product and lot details in each record.
- Z-1245-2023 · Jan 30, 2023 · Open, ClassifiedFusion Bioline Vascular Graft, Part number M00201503046B0
Other Prosthesis, Vascular Graft, Of 6mm And Greater Diameter devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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