Hemagard HGKUT0007-40Recalls & reported problems
Intervascular Sas · Hemagard Knitted Ultrathin Straight Collagen Coated Vascular Graft · Class 2 · Implant
All models of Hemagard (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00384401014713), received between Aug 10, 2016 and Jun 14, 2022 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information4
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding4
- Pseudoaneurysm4
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED TO INTERVASCULAR THAT A LEAKAGE VASCULAR GRAFT WAS OBSERVED AFTER 2 YEARS OF IMPLANTATION (2014 - 2016). THE LEAKS WERE "REPAIRED" WITH 2 STENTS, WITHOUT EXPLANTING THE GRAFT. THE GRAFT WAS IMPLANTED IN 2014, A FEM-POP PROCEDURE WAS CONDUCTED. COMPLAINT # (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm
MAUDE report 14688150 ↗InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED TO INTERVASCULAR THAT A LEAKAGE VASCULAR GRAFT WAS OBSERVED AFTER 6 YEARS OF IMPLANTATION (2012 - 2018). THE LEAKS WERE "REPAIRED" WITH 1 STENT, WITHOUT EXPLANTING THE GRAFT. THE GRAFT WAS IMPLANTED IN 2012, A FEM-POP PROCEDURE WAS CONDUCTED. COMPLAINT #(B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm
MAUDE report 14688140 ↗InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED TO INTERVASCULAR THAT A LEAKAGE VASCULAR GRAFT WAS OBSERVED AFTER 2 YEARS OF IMPLANTATION (2014 - 2016). THE LEAKS WERE "REPAIRED" WITH 2 STENTS, WITHOUT EXPLANTING THE GRAFT. THE GRAFT WAS IMPLANTED IN 2014, A FEM-POP PROCEDURE WAS CONDUCTED. COMPLAINT # (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm
MAUDE report 14675846 ↗InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED TO INTERVASCULAR THAT A LEAKAGE VASCULAR GRAFT WAS OBSERVED AFTER 6 YEARS OF IMPLANTATION (2012 - 2018). THE LEAKS WERE "REPAIRED" WITH 1 STENT, WITHOUT EXPLANTING THE GRAFT. THE GRAFT WAS IMPLANTED IN 2012, A FEM-POP PROCEDURE WAS CONDUCTED. COMPLAINT #(B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm
MAUDE report 14675839 ↗MalfunctionAug 10, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING THE LEAK TEST PERFORMED ON (B)(6) 2016 PRIOR TO THE SURGICAL PROCEDURE WITH A SALINE SOLUTION, THE INVOLVED GRAFT APPEARED TO BE PERMEABLE. SO THE GRAFT WAS NOT USED FOR IMPLANTATION AND WAS IMMEDIATELY CHANGED WITH ANOTHER ONE. THE INVOLVED DEVICE WAS NOT KEPT FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5864359 ↗
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
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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