IntergardRecalls & reported problems across all models

We found 41 models of Intergard by Intervascular Sas in the FDA's device registry (GUDID). Together they are named in 165 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2015 and Sep 3, 2026 — classified as 6 deaths, 81 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (57 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Intergard recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 29, 2022Terminated

   Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm

   Z-1282-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported Intergard problems

Intergard models

41 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Intergard IGW0032-30

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 recall2 reports
• Intergard HEWAA2810080810/1

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  12 reports
• Intergard HEWAA3010080810/1

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  12 reports
• Intergard HEWAA2610080810/1

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  2 deaths10 reports
• Intergard IGW0028-30

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  9 reports
• Intergard IGK1608

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  9 reports
• Intergard IGW0008-30

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  7 reports
• Intergard IGW0028-15

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  2 deaths7 reports
• Intergard IGK1407

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  7 reports
• Intergard IGK1809

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  7 reports
• Intergard IGK0008-40

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  7 reports
• Intergard HEWAA2410080810/1

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  7 reports
• Intergard IGW0030-30

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  5 reports
• Intergard IGK0008-70

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  5 reports
• Intergard IGK2010

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  5 reports
• Intergard IGK0008RS45

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  5 reports
• Intergard IGW0026-15

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  4 reports
• Intergard IGW0030-15

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  4 reports
• Intergard IGW0010-30

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  3 reports
• Intergard IGW0026-30

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  3 reports
• Intergard IGK0010-40

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  3 reports
• Intergard IGK1206

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 death3 reports
• Intergard IGKAX0808RS45/30

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  3 reports
• Intergard IGKAX100808RS35/20

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  3 reports
• Intergard IGW0020-30

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  2 reports
• Intergard IGW0032-15

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  2 reports
• Intergard IGKUT0008-70

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  2 reports
• Intergard HEW3210BRIDGE

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  2 reports
• Intergard IGK0008-20

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  2 reports
• Intergard HEWAA2010080810/1

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  2 reports
• Intergard IGW0018-15

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• Intergard IGW0022-30

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• Intergard IGK0006-70

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• Intergard IGK0016-40

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• Intergard IGK0018-40

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• Intergard IGK0007-70

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• Intergard HEW3010BRIDGE

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 death1 report
• Intergard HEW2610BRIDGE

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• Intergard IGKUT0007-40

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• Intergard IGKUT0008-40

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• Intergard IGK0020-40

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report

Recent Intergard adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Leak/Splash

  It was reported to Intervascular that during the surgical procedure, porosity of the graft was identified at several locations, resulting in bleeding from multiple positions. The bleeding stopped spontaneously and the patient is currently in good condition. The patient is well and stable.Complaint (b)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50591580 ↗
• MalfunctionAug 7, 2026Product Quality Problem

  Complaint #(b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173515 ↗
• MalfunctionAug 7, 2026Product Quality Problem

  Complaint #(b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173358 ↗
• 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 ↗
• MalfunctionApr 20, 2026Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE DOCTOR OPENED THE PACKAGE, HE FOUND THERE WAS YELLOW DOT ON THE SURFACE OF THE GRAFT. THEN HE USED ANOTHER NEW ONE TO COMPLETE THE SURGERY. COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922656 ↗
• MalfunctionApr 20, 2026Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE DOCTOR OPENED THE PACKAGE, HE FOUND THERE WAS YELLOW DOT ON THE SURFACE OF THE GRAFT. THEN HE USED ANOTHER NEW ONE TO COMPLETE THE SURGERY. COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922282 ↗
• 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 24715127 ↗
• 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 ↗
• 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 24714692 ↗
• 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 24714685 ↗
• 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 24714672 ↗
• 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 24714385 ↗
• 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 24714259 ↗
• 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, (B)(4) 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 24714124 ↗

Other Intervascular Sas products

• Hemashield51 models · 149 reports · 4 recalls
• Hemagard28 models · 93 reports
• Cardioroot6 models · 35 reports · 1 recall