Intergard IGK0008-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00384401000938), received between Oct 12, 2015 and Mar 30, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Moisture or Humidity Problem

  IT WAS REPORTED TO INTERVASCULAR THAT THE CUSTOMER ALLEGED THAT HUMIDITY LEVELS WERE OVER 80% FOR MORE THAN 24 HOURS AND DID REACH 100%. THE DISTRIBUTOR, INTERMED HAD ONE OF REPS VISIT THE CUSTOMER SITE FOR AN ON-SITE INSPECTION OF THE PRODUCTS. SOME PRODUCTS HAD BUBBLING ON THE LABELLING. IT WAS DESCRIBED THAT ALL PRODUCTS FELT COLD AS IF LIKE THEY WERE DEFROSTED. IT WAS SUSPECTED THAT THE PRODUCTS WERE EXPOSED TO EXTREMELY HIGH LEVELS OF MOISTURE. THE IMPACTED PRODUCTS INCLUDE 12 INTERVASCULAR HEMAGARD AND INTERGARD GRAFTS. TWELVE SEPARATE COMPLAINTS WERE CREATED FOR EACH AFFECTED PRODUCTS. ACCORDINGLY, TWELVE INDIVIDUAL EMDR SUBMISSIONS WILL BE SUBMITTED. THIS EMDR IS PART OF A SERIES OF TWELVE EMDRS SUBMITTED FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714860 ↗
• InjuryJul 10, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING A REPAIR OF ASCENDING AORTA DISSECTION PERFORMED ON (B)(6) 2017, IT WAS REPORTED THAT THE LEFT AXILLARY ARTERY WAS CANNULATED THROUGH THE INTERGARD 8 MM GRAFT. AFTER IMPLANTATION, THE GRAFT STARTED LEAKING RESULTING IN SIGNIFICANT BLOOD LOSS. A CONTINUOUS BLOOD TRANSFUSION WAS REQUIRED TILL THE END OF THE PROCEDURE. THE PATIENT IS RECOVERING; NO CONSEQUENCE FOR THE PATIENT WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 6697165 ↗
• InjuryApr 14, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING THE IMPLANTATION OF THE INVOLVED GRAFT AS A CANNULA FOR AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), AFTER ASCENDING AORTA REPLACEMENT PERFORMED ON (B)(6) 2017, THE GRAFT WAS REPORTED TO BLEED. INDEED, AFTER RELEASING THE BLOOD FLOW, DIFFUSE BLEEDING WAS OBSERVED THROUGH THE GRAFT, WHICH NECESSITATED TO REPLACE IT BY ANOTHER GRAFT. IT LED TO AN EXTENDED OPERATION TIME : THE IMPLEMENTATION OF ECMO WAS RETARDED WHEREAS THE PATIENT WAS IN CARDIOGENIC SHOCK. NO INFORMATION ABOUT THE CONSEQUENCE FOR PATIENT COULD HAVE BEEN OBTAINED AT THIS DATE.

  Patient problems: Blood Loss

  MAUDE report 6493302 ↗
• InjuryMar 21, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, DURING A MINI INVASIVE CARDIAC PROCEDURE, THE GRAFT WAS USED FOR AN EXTRACORPOREAL CIRCULATION (ECC). THE SURGEON NOTICED BLEEDING FROM THE GRAFT, WHICH WAS EXPECTED BUT ACCORDING TO HIS EXPERIENCE, IT WAS TOO MUCH. IT WAS REPORTED THAT THE BLEEDING PROLONGED THE DURATION OF THE PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITHOUT REPLACING THE GRAFT. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 6420106 ↗
• InjuryNov 30, 2015Insufficient Device Problem Information

  DURING A VASCULAR BYPASS SURGERY PERFORMED ON (B)(6) 2015, A GRAFT OOZING WAS REPORTED AFTER THE ANASTOMOSIS. THE GRAFT WAS EXPLANTED AND ANOTHER GRAFT WAS USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5255244 ↗
• InjuryOct 13, 2015Manufacturing, Packaging or Shipping Problem

  THE GRAFT WAS REMOVED AND AN OTHER GRAFT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Blood Loss

  MAUDE report 5146624 ↗
• InjuryOct 12, 2015Manufacturing, Packaging or Shipping Problem

  THE GRAFT WAS REMOVED AND AN OTHER GRAFT WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 5144192 ↗

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