Hemagard Carotid Patch HGKTP06/75CPUT (1)Recalls & reported problems
Intervascular Sas · Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00384401015192), received between Sep 23, 2016 and Apr 12, 2019 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 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
- Manufacturing, Packaging or Shipping Problem2
- Product Quality Problem2
Patient problems
- Blood Loss2
- No Patient Involvement2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2019Product Quality Problem; Product Quality Problem
THE REFERENCE LINE OF THE INVOLVED PATCH WAS NOT STRAIGHT, IMPLANTATION OF THE DEVICE WAS NOT POSSIBLE. THE SAME HAPPENED WITH ANOTHER PATCH OF THE SAME LOT (SEE MANUFACTURER REPORT 1640201-2019-00025 FOR THE OTHER INVOLVED DEVICE). ANOTHER PRODUCT WAS USED INSTEAD.
Patient problems: No Patient Involvement
MAUDE report 8510437 ↗MalfunctionApr 12, 2019Product Quality Problem; Product Quality Problem
THE REFERENCE LINE OF THE INVOLVED PATCH WAS NOT STRAIGHT, IMPLANTATION OF THE DEVICE WAS NOT POSSIBLE. THE SAME HAPPENED WITH ANOTHER PATCH OF THE SAME LOT (SEE MANUFACTURER REPORT 1640201-2019-00026 FOR THE OTHER INVOLVED DEVICE). ANOTHER PRODUCT WAS USED INSTEAD.
Patient problems: No Patient Involvement
MAUDE report 8510436 ↗InjurySep 23, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING A SURGERY INVOLVING TWO VASCULAR PATCHES, IT WAS REPORTED THAT AN IMPORTANT LEAKAGE WAS OBSERVED FROM THE PATCH. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE SURGEON SUTURED THE CAROTID TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCE FOR THE PATIENT HAS BEEN REPORTED.
Patient problems: Blood Loss
MAUDE report 5972289 ↗InjurySep 23, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING A SURGERY INVOLVING TWO VASCULAR PATCHES, IT WAS REPORTED THAT AN IMPORTANT LEAKAGE WAS OBSERVED FROM THE PATCH. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE SURGEON SUTURED THE CAROTID TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCE FOR THE PATIENT HAS BEEN REPORTED.
Patient problems: Blood Loss
MAUDE report 5972288 ↗
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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