Hemagard HGKAX1010Recalls & reported problems
Intervascular Sas · Hemagard Knitted Axillo-bifemoral 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
- 2
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401014478), received between Aug 18, 2023 and Aug 22, 2023 — classified as 2 deaths.
The most frequently reported specific device problem is “Material Puncture/Hole” (2 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.
Most reported problems
Device problems
- Material Puncture/Hole2
- Off-Label Use2
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathAug 22, 2023Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole
DeathAug 18, 2023Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole
IT WAS REPORTED TO INTERVASCULAR BY THE HOSPITAL THAT A PATIENT PRESENTED WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) AND HAD AN INTRA-AORTIC BALLOON PUMP (IABP) PLACED. PLAN WAS TO INITIATE VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) THEN HAVE CORONARY STENT PLACEMENT. PROCEDURES PERFORMED IN CATHERIZATION LABORATORY. RIGHT GROIN WITH 8FR CATHETER AND IABP BUT WAS OCCLUSIVE DUE TO SEVERE PERIPHERAL VASCULAR DISEASE (PVD). FEMORAL VENOUS ACCESS OBTAINED FOR ECMO AND LEFT AXILLARY CUTDOWN PERFORMED FOR ARTERIAL ACCESS. END TO SIDE ANASTOMOSIS PERFORMED TO LEFT AXILLARY ARTERY AND HEMAGARD GRAFT. IMPELLA INSERTED INTO 1 LIMB WITH 3/8-3/8 CONNECTOR TO OTHER LIMB AND THEN TO ECMO. FLOW RATE WAS 3.5 L/MIN WITH SYSTEM PRESSURE OF 220-230 MMHG. PINHOLE BLEEDING OCCURRED ALONG GRAFT, SUTURE LINES, AND SEAM OF BRANCHED GRAFT. HEMOSTATIC AGENTS USED WITHOUT DESIRED RESULTS WHICH INCLUDED EVARREST, EVASEAL, NU-KNIT, AND QUICK CLOT. ACTIVATED CLOTTING TIME (ACT) WAS REPORTED TO BE 140'S AND NO HEPARIN WAS GIVEN DURING THE PROCEDURE. PATIENT WITH HISTORY OF TAKING ELLIQUIS FOR ATRIAL FIBRILLATION. IMPELLA WAS REMOVED WITH CLAMPING OF GRAFT LIMB WITHOUT RESOLUTION OF
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17571637 ↗
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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