Intergard IGK1608Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00384401000488), received between Jul 19, 2016 and Mar 30, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (4 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 9 most recent of 9 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 24713960 ↗
• InjuryAug 2, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED TO INTERVASCULAR THAT THE LIMB OF GRAFT WAS POROUS. A PIECE OF THE LIMB WAS USED TO DO A FEMORAL-TO-FEMORAL BYPASS. AFTER 1ST ANASTOMOSIS, GRAFT WAS POURING OUT BLOOD THROUGH MATERIAL OF GRAFT . COMPLAINT # (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17442408 ↗
• InjuryJul 24, 2023Nonstandard Device; Nonstandard Device

  COMPLAINT #(B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17377206 ↗
• MalfunctionMar 14, 2023Nonstandard Device; Nonstandard Device

  COMPLAINT #(B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16541974 ↗
• MalfunctionMar 8, 2023Nonstandard Device; Nonstandard Device

  COMPLAINT #(B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16501297 ↗
• InjuryDec 20, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  SINCE ONE MONTH POST-IMPLANTATION OF A FIRST GRAFT ON (B)(6) 2014 (SEE MEDICAL DEVICE REPORT 1640201-2018-00030), THE PATIENT HAS HAD AN EXTREMELY COMPLEX CLINICAL PRESENTATION WITH RECURRENT FEVER OF UNKNOWN ORIGIN, RECURRENT PYELONEPHRITIS DUE TO URETERAL COMPRESSION WITH PLACEMENT OF DJ STENTS AND DISCOVERY OF GRAFT/URETER CONFLICT. A SECOND GRAFT (THE SUBJECT OF THIS REPORT) WAS IMPLANTED ON (B)(6) 2016 AND SYMPTOMS CONTINUED. THE PATIENT HAS BEEN THE SUBJECT OF NUMEROUS INVESTIGATIONS. A "CONTACT VASCULITIS" TO DACRON GRAFTS WAS DIAGNOSED. ALL INVESTIGATIONS MADE BY THE HOSPITAL ARE DESCRIBED IN THE ATTACHED FILE. THE AFFECTED GRAFTS WERE NOT EXPLANTED FROM THE PATIENT YET.

  Patient problems: Fever; Hypersensitivity/Allergic reaction

  MAUDE report 8184307 ↗
• InjuryNov 23, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING AN ABDOMINAL AORTIC ANEURYSM SURGERY PERFORMED ON (B)(6) 2016, BLOOD LEAK WAS NOTED FROM THE BIFURCATION OF THE MAIN SEGMENT. BLOOD SPOTS WERE OOZING FROM THE GRAFT BUT IT IS UNKNOWN HOW MUCH BLOOD LEAKED. THE PRODUCT WAS STRETCHED DURING SURGERY. THE GRAFT WAS REMOVED AND REPLACED BY A IGK1407 GRAFT TO COMPLETE THE SURGERY. THE SURGERY WAS FINISHED WITH NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: Blood Loss

  MAUDE report 6124756 ↗
• InjuryNov 22, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING AN ABDOMINAL AORTIC ANEURYSM SURGERY PERFORMED ON (B)(6) 2016, IT WAS REPORTED A BLOOD LEAK FROM THE BIFURCATION OF THE MAIN SEGMENT. LEG BRANCH WAS CUT AND CENTER AREA WAS USED FOR STRAIGHT PIPE TO CONTINUE THE SURGERY. NO ADVERSE CONSEQUENCE FOR THE PATIENT WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 6119998 ↗
• MalfunctionJul 19, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING AN ABDOMINAL AORTIC ANEURYSM SURGERY PERFORMED ON (B)(6) 2016, IT WAS REPORTED A BLOOD LEAKING FROM THE ENTIRE SURFACE OF THE GRAFT WHEN DECLAMPED AFTER THE ANASTOMOSIS OF THE LEFT COMMON ILIAC ARTERY. THE BLEEDING STOPPED BY ITSELF AFTER HALF AN HOUR. THE GRAFT REMAINED IMPLANTED. NO ADVERSE CONSEQUENCE FOR THE PATIENT HAS BEEN REPORTED.

  Patient problems: Blood Loss

  MAUDE report 5805076 ↗

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 · Terminated
  InterGard 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 · 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