Hemagard Carotid Patch HGKTP08/75CPUT (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
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00384401015208), received between Jun 15, 2018 and Jan 29, 2025 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Nonstandard Device2
- Device Markings/Labelling Problem1
- Inaccurate Information1
- Labelling, Instructions for Use or Training Problem1
- Material Frayed1
- Product Quality Problem1
Patient problems
- Blood Loss2
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2025Product Quality Problem; Product Quality Problem
COMPLAINT #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21264593 ↗MalfunctionOct 30, 2024Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem
AN EXPIRED PRODUCT, WITH AN INCORRECT LABEL IS PHYSICALLY LOCATED AT A CUSTOMER IN MEXICO, BUT STILL REGISTERED IN THE US IN THE ERP (ENTERPRISE RESOURCE PLANNING) SYSTEM. AT THE REQUEST OF A CUSTOMER, GETINGE MEXICO SUBSIDIARY ASKED INTERVASCULAR CUSTOMER SERVICE TO CHECK WHERE A PRODUCT HAS COME FROM. TO DO THIS, THEY PROVIDED A PHOTO OF THE PRODUCT BOX ALONG WITH ITS LABEL. WHEN CUSTOMER SERVICE HAS TRACKED DOWN THE SERIAL NUMBER FROM THE PHOTO, THEY REALISED THAT THE PRODUCT REFERENCE ON THE PICTURE DID NOT MATCH THE ASSOCIATED SERIAL NUMBER IN THE SYSTEM. ADDITIONALLY, IT TURNS OUT THAT THE EXPIRY DATE DOESN'T MATCH EITHER AND HAD ALREADY PASSED. THIS PRODUCT WAS OFFERED BY ANOTHER ENTITY TO ONE OF GETINGE CUSTOMERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20567357 ↗InjuryFeb 25, 2021Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem
THE COMPLAINT DESCRIPTION WE RECEIVED IS AS FOLLOWS: "CONTINUOUS BLEEDING DURING THE SUTURE, LASTING MORE THAN 150 MIN. THIS CUSTOMER HAS A HUGE EXPERIENCE WITH OUR PATCHES AND IT'S THE FIRST TIME HE HAS THIS PROBLEM." THE FOLLOWING CUSTOMER REPORT WAS ATTACHED IN THE COMPLAINT FILE: "SURGICAL INTERVENTION: MR. XX, (B)(6) YEARS OLD. THE SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2021, AND IT WAS PERFORMED A LEFT CAROTID ENDARTERECTOMY WITH SHUNT. THE PATIENT WAS UNDERGOING ANTIPLATELET THERAPY WITH CLOPIDOGREL. SURGERY WAS PERFORMED UNDER GENERAL ANESTHESIA WITH SYSTEMIC INTRAOPERATIVE HEPARINIZATION (50 MG). AFTER PATCH SUTURE WITH PROLENE 5/0 VISIBLACK, AND REVERSION WITH PROTAMINA 1:1, IT WAS OBSERVED A PERSISTENT BLEEDING TROUGH THE PATCH PORES. IN THAT MOMENT, IT WAS ADDED 30 MG MORE OF PROTAMINE TO TRY REVERSION. VERY DIFFICULT HEMOSTASIS, IN ADDITION WERE USED SURGICEL, TACHOCIL FOR MORE THAN 150M. FINALLY, IT WAS POSSIBLE TO REACH LOCAL HEMOSTASIS. CLOSING SUTURE WITH VYCRIL AND LEFT WITH REDÓN. WE SUSPECT A POSSIBLE DEFECT IN PATCH TISSUE. " ADDITIONAL INFORMATION ON THE EVENT AND PATIENT STATUS WAS FURTHER RECEIVED IN THE CONTEXT OF COMPLAINT INVESTIGATION: CURRENTLY, THE
Patient problems: Blood Loss
MAUDE report 11380596 ↗InjuryFeb 25, 2021Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem
SEE INITIAL MFR REPORT 1640201-2021-00006. COMPLAINT # (B)(4).
Patient problems: Blood Loss
MAUDE report 11377475 ↗MalfunctionApr 8, 2020Inaccurate Information; Inaccurate Information
SEE INITIAL MFR REPORT#1640201-2020-00009. COMPLAINT # (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9937990 ↗MalfunctionJun 15, 2018Material Frayed; Material Frayed
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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