Intergard IGKUT0007-40Recalls & reported problems
Intervascular Sas · Intergard Knitted Ultrathin Straight Collagen Coated Vascular Graft · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384401001263), received between Dec 20, 2018 and Dec 20, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
1 other recall cover devices cleared under the same FDA submission (K983819); 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
Device problems
- Patient-Device Incompatibility1
Patient problems
- Fever1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2018Patient-Device Incompatibility; Patient-Device Incompatibility
SINCE ONE MONTH POST-IMPLANTATION OF THE GRAFT ON (B)(6) 2014, 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 WAS IMPLANTED ON (B)(6) 2016 (SEE MEDICAL DEVICE REPORT 1640201-2018-00031). 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 FILE. THE AFFECTED GRAFTS WERE NOT EXPLANTED FROM THE PATIENT YET.
Patient problems: Fever; Hypersensitivity/Allergic reaction
MAUDE report 8184306 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K983819. One submission often covers many models, so check the product and lot details in each record.
- Z-0638-04 · Dec 30, 2003 · TerminatedHemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; H
Other Prosthesis, Vascular Graft, Of 6mm And Greater Diameter devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.