Hemagard HGKAX0808RS45/30Recalls & reported problems
Intervascular Sas · Hemagard Knitted Axillo-bifemoral Radially Supported Collagen Coated Vascular Graft · Class 2 · Implant
All models of Hemagard (28)
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 00384401014812), received between Oct 24, 2017 and Oct 24, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
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.
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING AN AXILLO-BIFEMORAL CASE, AFTER THE PHYSICIAN TOOK CLAMPS OFF, IMMEDIATELY BLOOD STARTED WEEPING PROFUSELY THROUGH THE HEMAGARD GRAFT. THE PATIENT HAD 10,000 UNITS OF HEPARIN IN THE BEGINNING OF THE PROCEDURE AND AN ADDITIONAL 2000 UNITS OF HEPARIN MID PROCEDURE. THE MEDICAL STAFF AND PHYSICIAN CHOSE NOT TO REVERSE HEPARIN. THE BLOOD LEAKING STOPPED AFTER 20 MINUTES. THE GRAFT REMAINED IMPLANTED AND THE PATIENT WAS STABLE. IT WAS ALSO REPORTED THAT THIS WAS PHYSICIAN'S FIRST CASE USING AN HEMAGARD GRAFT.
Patient problems: Blood Loss
MAUDE report 6972795 ↗
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-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
- 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
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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