Intergard IGKAX0808RS45/30Recalls & reported problems
Intervascular Sas · Intergard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft · Class 2 · Implant
All models of Intergard (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384401000877), received between Sep 23, 2016 and Jun 25, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 reports).
2 other recalls cover devices cleared under the same FDA submission (K964625); 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.
Reports received per month
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem3
- Off-Label Use2
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
- Blood Loss1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2024Off-Label Use; Manufacturing, Packaging or Shipping Problem; Off-Label Use; Manufacturing, Packaging or Shipping Problem
InjuryJun 24, 2024Off-Label Use; Manufacturing, Packaging or Shipping Problem; Off-Label Use; Manufacturing, Packaging or Shipping Problem
MalfunctionSep 23, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING AN ILIAC ARTERY ANEURYSM SURGERY PERFORMED ON (B)(6) 2016, IT WAS REPORTED THAT EXCESSIVE BLOOD LEAKING OCCURRED FROM THE PART OF THE BRANCH GRAFT WITHOUT RINGS. THIS BLEEDING OCCURRED WHEN DECLAMPING THE GRAFT AFTER ANASTOMOSING THE MAIN SEGMENT WITH THE PATIENT VESSEL. THE BLEEDING FINALLY STOPPED BY ITSELF WITHOUT ANY MEDICAL OR SURGICAL INTERVENTION AND THE SURGERY WAS COMPLETED. THE PATIENT WAS REPORTED AS BEING FINE.
Patient problems: Blood Loss
MAUDE report 5972525 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K964625. One submission often covers many models, so check the product and lot details in each record.
- Z-1427-2010 · Dec 9, 2009 · TerminatedInterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in th
- Z-1439-2010 · Dec 9, 2009 · TerminatedInterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K9842
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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