Intergard IGK2010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00384401000501), received between Jun 14, 2019 and Mar 30, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (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.

• 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 24713881 ↗
• InjuryJul 24, 2023Nonstandard Device; Product Quality Problem; Nonstandard Device; Product Quality Problem

  COMPLAINT#: (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17378714 ↗
• InjuryJul 19, 2023Nonstandard Device; Product Quality Problem; Nonstandard Device; Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR FROM THE HOSPITAL THAT WHEN THE PROSTHESIS WAS PUT IN PLACE, THE CUSTOMER NOTICED IT WAS POROUS AND LOCALIZED BLEEDING WAS OBSERVED. STITCHES WERE PERFORMED TO STOP THE BLEEDING, THEREFORE THE SURGERY WAS DELAYED. THE PRODUCT REMAINED IMPLANTED. TO DATE, A PATIENT INJURY IS UNKNOWN. THE SURGEON IS EXPERIENCED WITH INTERGARD PRODUCTS. PLEASE NOTE THAT ANOTHER CASE (COMPLAINT MANUFACTURER REFERENCE #849158) WITH THE SAME INITIAL DESCRIPTION AND INVOLVING A DIFFERENT PATIENT AND A DIFFERENT PRODUCT REFERENCE, WAS REPORTED BY THE SAME CUSTOMER AND ON THE SAME DATE. A SECOND MDR WILL BE SUBMITTED IN PARALLEL FOR THE ABOVE REFERENCED CASE. COMPLAINT MANUFACTURER REFERENCE (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17350290 ↗
• MalfunctionDec 3, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  SEE MFG REPORT #1640201-2021-00037 COMPLAINT #: (B)(4). ON DECEMBER 16, 2021 WE RECEIVED ADDITIONAL INFORMATION THAT THE PRODUCT COULD NOT BE RETURNED AS IT WAS REQUESTED BY THE HOSPITAL. THE PRODUCT WAS IMPLANTED. THE PATIENT'S STATUS IS GOOD. THE HOSPITAL ACCEPTED DAMAGED BOXES AS ITS ONLY CARDBOARD AND THE INTERNAL PACKAGING WAS INTACT WITHOUT ANY TRACES OF DAMAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923775 ↗
• InjuryJun 14, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING THE OPERATION OF A THORACOABDOMINAL AORTIC ANEURYSM, AN HEMASHIELD GRAFT WAS USED. THE COMPLAINT INTERGARD GRAFT WAS ANASTOMOSED ON THE PERIPHERAL SIDE OF THE HEMASHIELD GRAFT. THEN, WHEN THE CLAMP WAS RELEASED, BLOOD LEAKAGE WAS OBSERVED FROM THE ENTIRE INTERGARD GRAFT. AFTER NEUTRALIZING WITH PROTAMINE, BLOOD LEAKAGE GRADUALLY STOPPED. THE PRODUCT IS NOT RETURNED BECAUSE IT IS IMPLANTED IN THE PATIENT'S BODY.

  Patient problems: Blood Loss

  MAUDE report 8699979 ↗

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