Graft, Vascular, Synthetic/Biologic Composite
FDA adverse event reports and recall history for graft, vascular, synthetic/biologic composite (product code MAL), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 877
- Deaths
- 43
- Injuries
- 378
- Malfunctions
- 452
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-06-26TerminatedError in labeling
Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
- 2015-06-26TerminatedError in labeling
Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
- 2013-07-22TerminatedProcess control
AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Blood blushing/leaking from the surface of the graft after implantation
- 2013-07-22TerminatedProcess control
AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Blood blushing/leaking from the surface of the graft after implantation
- 2013-07-22TerminatedProcess control
Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Blood blushing/leaking from the surface of the graft after implantation
- 2013-07-22TerminatedProcess control
AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Blood blushing/leaking from the surface of the graft after implantation
- 2013-07-22TerminatedProcess control
AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Blood blushing/leaking from the surface of the graft after implantation
- 2013-07-22TerminatedProcess control
AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Blood blushing/leaking from the surface of the graft after implantation
- 2013-07-22TerminatedProcess control
AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Blood blushing/leaking from the surface of the graft after implantation
- 2013-07-22TerminatedProcess control
AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Blood blushing/leaking from the surface of the graft after implantation
Monitor graft, vascular, synthetic/biologic composite automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.