Intergard IGK0008-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00384401000372), received between Dec 18, 2019 and May 29, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS EVENT WAS COLLECTED AS PART OF THE INTERVASCULAR PMCF REGISTRY. PATIENT (B)(6) EXPERIENCED AN INTERGARD BYPASS GRAFT INFECTION ON (B)(6) 2016. THE ADVERSE EVENT WAS CATEGORIZED AS MAJOR ADVERSE LIMB EVENT (MALE) AND INFECTION RELATED TO THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED WITH GRAFT REINTERVENTION BUT WITH NO AMPUTATION. THE CLINIC NOTED THAT THIS AE WAS NOT RELATED TO PROCEDURE BUT RELATIONSHIP TO THE DEVICE WAS CAUSAL. THE CLINIC PROVIDED THE FOLLOWING DETAILS, "SINCE THE LAST FEMOROTIBIAL PROSTHETIC GRAFT INFECTION, THE PATIENT HAD A CHRONIC INFECTION MANAGED WITH DOXYCYCLINE SINCE 2017. HE WAS HOSPITALIZED ON (B)(6) 2019, FOR A CLINICAL PRESENTATION OF A MARKEDLY SWOLLEN, ERYTHEMATOUS RIGHT LEG WITH PURULENT DISCHARGE AT THE ANTERIOR FEMOROTIBIAL SURGICAL SITE. DUS DEMONSTRATED A PERIPROSTHETIC COLLECTION EXTENDING ALONG THE ENTIRE FEMOROTIBIAL BYPASS GRAFT. ON (B)(6) 2019, THE PATIENT UNDERWENT REPLACEMENT OF THE RIGHT ANTERIOR PROSTHETIC FEMOROTIBIAL BYPASS WITH AN ANTERIOR FEMOROTIBIAL BYPASS USING A VENOUS ALLOGRAFT. DURING THE SAME PROCEDURE, THE INFECTED INTERGARD ILIOFEMORAL PROFUNDA BYPASS WAS ALSO REPLACED WITH AN ILIOFEMORAL PROFUNDA BYPASS USING A VEN

  Patient problems: Bacterial Infection

  MAUDE report 25331188 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS EVENT WAS COLLECTED AS PART OF THE INTERVASCULAR PMCF REGISTRY. PATIENT (B)(6) EXPERIENCED AN INTERGARD BYPASS GRAFT INFECTION ON 16DEC2016. THE ADVERSE EVENT WAS CATEGORIZED AS MAJOR ADVERSE LIMB EVENT (MALE) AND INFECTION RELATED TO THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED WITH GRAFT REINTERVENTION BUT WITH NO AMPUTATION. THE CLINIC NOTED THAT THIS AE WAS NOT RELATED TO PROCEDURE BUT RELATIONSHIP TO THE DEVICE WAS CAUSAL. THE CLINIC PROVIDED THE FOLLOWING DETAILS, "SINCE THE LAST FEMOROTIBIAL PROSTHETIC GRAFT INFECTION, THE PATIENT HAD A CHRONIC INFECTION MANAGED WITH DOXYCYCLINE SINCE 2017. HE WAS HOSPITALIZED ON (B)(6) 2019, FOR A CLINICAL PRESENTATION OF A MARKEDLY SWOLLEN, ERYTHEMATOUS RIGHT LEG WITH PURULENT DISCHARGE AT THE ANTERIOR FEMOROTIBIAL SURGICAL SITE. DUS DEMONSTRATED A PERIPROSTHETIC COLLECTION EXTENDING ALONG THE ENTIRE FEMOROTIBIAL BYPASS GRAFT. ON (B)(6) 2019, THE PATIENT UNDERWENT REPLACEMENT OF THE RIGHT ANTERIOR PROSTHETIC FEMOROTIBIAL BYPASS WITH AN ANTERIOR FEMOROTIBIAL BYPASS USING A VENOUS ALLOGRAFT. DURING THE SAME PROCEDURE, THE INFECTED INTERGARD ILIOFEMORAL PROFUNDA BYPASS WAS ALSO REPLACED WITH AN ILIOFEMORAL PROFUNDA BYPASS USING A VENOU

  Patient problems: Bacterial Infection

  MAUDE report 25330705 ↗
• InjuryAug 29, 2023Off-Label Use; Product Quality Problem; Off-Label Use; Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR THAT FOLLOWING THE PLACEMENT OF THE INVOLVED DEVICE, OOZING OCCURRED ALONG ITS ENTIRE LENGTH. THE OOZING WAS ABNORMAL AND COPIOUS, RESULTING IN SIGNIFICANT BLOOD LOSS. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER INDICATES THAT THE DEVICE WAS USED TO CONNECT THE AXILLARY ARTERY TO THE ARTERY LINE OF EXTRA CORPOREAL CIRCULATION IN AORTIC DISSECTION TYPE A. THE PATIENT WAS AFFECTED BY VALVE AORTIC ENDOCARDITIS, PRE-OP COAGULATING TESTS WAS NORMAL. THE ACT WAS > 400. THE PATIENT WAS UNDER HEPARIN, AND ANTIBIOTICS FOR THE ENDOCARDITIS. THE SURGEON REPLACED THE ALREADY IMPLANTED PROTHESIS WITH ANOTHER OF THE SAME BRAND AND DIMENSIONS JUST A FEW MINUTES LATER AFTER THE IMPLANTATION. THE AMOUNT OF BLOOD LOSS IS UNKNOWN. ONLY ONE INTERVENTION ON THE PATIENT WAS NECESSARY. THE INTRA AND POST OPERATIVE COURSE WAS UNEVENTFUL. AFTER THAT, THE PATIENT WAS FINE. THE SURGEON LINKED THIS TO A POSSIBLE DEFECT ON THE COLLAGEN COATING. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED TO THE MANUFACTURER FOR EXAMINATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17643429 ↗
• InjuryAug 24, 2023Off-Label Use; Product Quality Problem; Off-Label Use; Product Quality Problem

  COMPLAINT #(B)(4)

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17610037 ↗
• MalfunctionDec 18, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  SEE INITIAL MFR REPORT # 1640201-2019-00092. COMPLAINT # (B)(4).

  Patient problems: Blood Loss

  MAUDE report 9490783 ↗

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 · Terminated
  InterGard 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 · Terminated
  InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in th