Hemagard HGKAX0808Recalls & 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
- 18
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00384401015109), received between Mar 21, 2018 and Mar 16, 2026 — classified as 15 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (14 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 Problem14
- Material Deformation2
- Nonstandard Device2
Patient problems
- Blood Loss6
- Hemorrhage/Blood Loss/Bleeding4
- No Clinical Signs, Symptoms or Conditions2
- Seroma2
- Thrombosis/Thrombus2
- Exsanguination1
- Failure of Implant1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2026Manufacturing, Packaging or Shipping Problem
InjuryMar 16, 2026Manufacturing, Packaging or Shipping Problem
InjuryMar 16, 2026Manufacturing, Packaging or Shipping Problem
InjuryMar 13, 2026Manufacturing, Packaging or Shipping Problem
InjuryMar 13, 2026Manufacturing, Packaging or Shipping Problem
InjuryMar 13, 2026Manufacturing, Packaging or Shipping Problem
THIS EVENT WAS SUBMITTED AS PART OF THE INTERVASCULAR PMCF REGISTRY ON APRIL 4, 2017, THE PATIENT WITH AORTIC OCCLUSIVE DISEASE IN THE ILIAC REGION HAD 100 PERCENT PRE-PROCEDURE STENOSIS. AN INTERGARD STANDARD AXILLO BIFEMORAL GRAFT WAS IMPLANTED, AN ILIAC STENT WAS ALSO IMPLANTED. DURING THIS PROCEDURE SUTURE HOLE BLEEDING OCCURRED AND A LOCAL HEMOSTATIC AGENT (TYPE UNKNOWN) WAS USED TO ARREST THE BLEEDING. TECHNICAL SUCCESS WAS ACHIEVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2017 ON (B)(6) 2017, 54 DAYS AFTER THE INITIAL IMPLANT, THE PATIENT EXPERIENCED THROMBOSIS OF THE CROSSED BRANCH OF THE AXILLO-BIFEMORAL BYPASS. THE SEVERITY WAS NOTED AS MODERATE AND THE INVESTIGATOR NOTED THIS WAS POSSIBLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE. ON (B)(6) 2022, 4 YEARS, 10 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE THE PATIENT EXPERIENCED PERIPROSTHETIC COLLECTION. THREE SEPARATE COMPLAINTS WERE CREATED FOR THESE THREE EVENTS. ACCORDINGLY, THREE INDIVIDUAL EMDR SUBMISSIONS WILL BE SUBMITTED FOR EACH EVENT. THIS REPORT IS THE FIRST IN A SERIES OF THREE REPORTS SUBMITTED FOR THIS PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24590410 ↗InjuryFeb 10, 2023Nonstandard Device; Nonstandard Device
InjuryFeb 7, 2023Nonstandard Device; Nonstandard Device
InjuryAug 25, 2022Material Deformation; Material Deformation
IT WAS REPORTED TO INTERVASCULAR THAT A HEMAGARD KNITTED GRAFT APPEARED TO BE MISSHAPED. ILL FITTED. IT WAS EXPLANTED AN ANOTHER GRAFT HAD TO BE USED. THE DEVICE NOT USED. THE HEMAGARD GRAFT WAS BEVELED, AND ANASTOMOSED TO THE COMMON FEMORAL AND ONTO THE SFA WITH A RUNNING 5-0 PROLENE SUTURE. AT WHICH TIME THEY ATTEMPTED TO FLUSH THE GRAFT AND KEPT GETTING RESISTANCE. MULTIPLE ATTEMPTS MADE TO STRAIGHTEN IT OUT BUT WAS DEEMED INADEQUATE AND WOULD NOT HOLD ITS SHAPE. THE SURGERY WAS NOT DELAYED BECAUSE OF THE EVENT SINCE THEY HAD A SECOND ONE ON THE SHELF READY FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15297069 ↗InjuryAug 18, 2022Material Deformation; Material Deformation
IT WAS REPORTED TO INTERVASCULAR THAT A HEMAGARD KNITTED GRAFT APPEARED TO BE MISSHAPED. ILL FITTED. IT WAS EXPLANTED AN ANOTHER GRAFT HAD TO BE USED. THE DEVICE NOT USED. THE HEMAGARD GRAFT WAS BEVELED, AND ANASTOMOSED TO THE COMMON FEMORAL AND ONTO THE SFA WITH A RUNNING 5-0 PROLENE SUTURE. AT WHICH TIME THEY ATTEMPTED TO FLUSH THE GRAFT AND KEPT GETTING RESISTANCE. MULTIPLE ATTEMPTS MADE TO STRAIGHTEN IT OUT BUT WAS DEEMED INADEQUATE AND WOULD NOT HOLD ITS SHAPE. THE SURGERY WAS NOT DELAYED BECAUSE OF THE EVENT SINCE THEY HAD A SECOND ONE ON THE SHELF READY FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15249595 ↗MalfunctionJun 6, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE EVENT TOOK PLACE DURING AN AXILLO-BIFEMORAL GRAFT OPERATION FOR A PATIENT WITH BILATERAL CRITICAL LIMB ISCHEMIA. AFTER TUNNELING THE GRAFT, THE SURGEON CHECKED FOR PATENCY (NO KINKING) WITH WATER. THERE WAS A GOOD FLOW BUT WATER WAS LEAKING FROM THE GRAFT THROUGHOUT. THE SURGEON FELT IT WOULD STILL LEAK PROFUSELY WITH BLOOD FLOWING THROUGH THE GRAFT THEREFORE IT WAS UNSAFE TO USE THE GRAFT WHICH CARRIES A SIGNIFICANT RISK FOR BLEEDING. THE GRAFT WAS THEREFORE NOT USED AND A DIFFERENT GRAFT WAS USED TO COMPLETE THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8674207 ↗InjuryMay 24, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE HOSPITAL REPORTED THAT DURING A GRAFT PROCEDURE, BLOOD OOZED THROUGH THE BODY OF THE GRAFT AND HAD TO BE REMOVED. A REPLACEMENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.
Patient problems: Blood Loss
MAUDE report 8639486 ↗MalfunctionFeb 21, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER IS REPORTING A BLEEDING EVENT DURING SURGERY. A SIGNIFICANT BLEEDING WAS OBSERVED THROUGHOUT THE ENTIRE GRAFT BODY AT THE TIME OF BYPASS RELEASE. THE SURGEON CLAMPED THE GRAFT, WAITED FOR A FEW MINUTES AND THEN RELEASED THE CLAMP AGAIN: BLEEDING STOPPED. THE GRAFT REMAINED IMPLANTED AND THE PATIENT IS RECOVERING WELL. A REMAINING FRAGMENT OF THE GRAFT IS AVAILABLE FOR INVESTIGATION.
Patient problems: Blood Loss
MAUDE report 8357092 ↗MalfunctionFeb 21, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER IS REPORTING A BLEEDING EVENT DURING SURGERY. A SIGNIFICANT BLEEDING WAS OBSERVED THROUGHOUT THE ENTIRE GRAFT BODY AT THE TIME OF BYPASS RELEASE. THE CUSTOMER CLAMPED AND AFTER A WHILE, DECLAMPED AGAIN, AND THE BLEEDING STOPPED.
Patient problems: Blood Loss
MAUDE report 8357088 ↗InjuryJan 16, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
WHEN THE FLOW WAS OPENED AFTER SUTURING THE GRAFT, THE WHOLE LENGTH OF THE GRAFT STARTED TO EXUDE BLOOD IN GREAT QUANTITY. DESPITE MANUAL COMPRESSION, INTERMITTENT CLAMPING AND REPLENISHMENT OF BLOOD AND FACTORS, THE PATIENT DEVELOPED AN HEMORRHAGIC SHOCK. THE TIME IN THE OPERATING ROOM BETWEEN THE COMPLETION OF THE BYPASS AND ACHIEVING AN ACCEPTABLE HEMOSTASIS WAS APPROXIMATELY 40 MINUTES. IT COMMITTED THE PATIENT'S LIFE AND REQUIRED INTERVENTION TO MAINTAIN HIS LIFE. MOREOVER, IT WAS NOTICED THAT THE GRAFT FRAYED WHEN IT WAS CUT AND WHEN IT WAS FIRMLY HELD WITH CLAMPS. REMAINING FRAGMENTS OF THE GRAFT ARE AVAILABLE FOR INVESTIGATION. A SECOND CASE WAS MENTIONED CONCERNING ANOTHER PATIENT IMPLANTED WITH A GRAFT IN AN AXILLARY POSITION AS WELL. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND HAD TO BE REOPERATED DUE TO BLEEDING POST SURGERY (SEE MEDICAL DEVICE REPORT 1640201-2019-00003).
Patient problems: Exsanguination
MAUDE report 8252230 ↗InjuryNov 29, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING AN AXILLO-BIFEMORAL GRAFT IMPLANTATION PROCEDURE, WHEN THE SURGEONS FLUSHED THE GRAFT, BLOOD LEAKAGE WAS OBSERVED THROUGH IT. NO CONSEQUENCE FOR THE PATIENT HAS BEEN REPORTED. ANOTHER GRAFT WAS USED.
Patient problems: Blood Loss; Failure of Implant
MAUDE report 8114439 ↗InjuryMar 21, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING A VASCULAR SURGERY, A PROBLEM WAS ENCOUNTERED WITH THE PERMEABILITY OF THE INVOLVED HEMAGARD AXILLO-BIFEMORAL GRAFT. AFTER THE DOCTOR TUNNELED THE GRAFT INSIDE THE PATIENT, THE BLOOD STARTED DIFFUSED FROM THE WHOLE SIDES OF THE GRAFT SO HE REMOVED IT, HE USED ANOTHER ONE. ALSO, HE FACED THE SAME PROBLEM WITH A 2ND GRAFT BUT HE MANAGED IT IN HIS OWN WAY (SEE MANUFACTURER REPORT 1640201-2018-00012 FOR THE SECOND INVOLVED DEVICE) . NO ADDITIONAL INFORMATION COULD BE OBTAINED AT THE DATE OF THIS REPORT.
Patient problems: Blood Loss
MAUDE report 7357354 ↗InjuryMar 21, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING A VASCULAR SURGERY, A PROBLEM WAS ENCOUNTERED WITH THE PERMEABILITY OF A GRAFT. AFTER THE DOCTOR TUNNELED THE GRAFT INSIDE THE PATIENT, THE BLOOD STARTED DIFFUSED FROM THE WHOLE SIDES OF THE GRAFT SO HE REMOVED IT, HE USED ANOTHER ONE. ALSO, HE FACED THE SAME PROBLEM WITH THE 2ND INVOLVED HEMAGARD AXILLO-BIFEMORAL GRAFT BUT HE MANAGED IT IN HIS OWN WAY (SEE MANUFACTURER REPORT 1640201-2018-00011 FOR THE FIRST INVOLVED DEVICE) . NO ADDITIONAL INFORMATION COULD BE OBTAINED AT THE DATE OF THIS REPORT.
Patient problems: Blood Loss
MAUDE report 7357337 ↗
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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