Hemagard HGKUT0008-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384401014768), received between Dec 23, 2016 and Jun 14, 2022 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Recent adverse event reports

The 3 most recent of 3 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 YEARS OF IMPLANTATION. THE LEAKS WERE "REPAIRED" WITH 2 STENTS, WITHOUT EXPLANTING THE GRAFT. THE GRAFT WAS IMPLANTED IN 2015, A FEM-POP PROCEDURE WAS CONDUCTED. DENATURALIZATION GRAFT?

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 14688072 ↗
• 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 YEARS OF IMPLANTATION. THE LEAKS WERE "REPAIRED" WITH 2 STENTS, WITHOUT EXPLANTING THE GRAFT. THE GRAFT WAS IMPLANTED IN 2015, A FEM-POP PROCEDURE WAS CONDUCTED. (DENATURALIZATION GRAFT?).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 14675442 ↗
• DeathDec 23, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE PATIENT UNDERWENT CORONARY ARTERIAL BYPASS SURGERY ON (B)(6) 2016. VASCULAR BYPASS WAS USED WITH INTERNAL MAMMARY ARTERY, SIGNS OF INFARCTUS WERE OBSERVED. THE PATIENT WAS IN INTENSIVE CARE UNIT, DURING THE NIGHT SHE DID NOT RECOVER AND DEVELOPED LEFT VENTRICULAR INSUFFICIENCY. SHE WAS RE-ADMITTED IN THE MORNING TO THE OPERATING ROOM FOR PLACEMENT OF ASSIST ECLS (EXTRACORPOREAL LIFE SUPPORT) WITH CARDIOHELP ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION). CARDIOHELP WAS PRIMED AND CONNECTED TO THE LEFT SUB-CLAVIAL ARTERY VIA INSERTION OF THE ECMO CANNULA IN THE INVOLVED GRAFT. CARDIOHELP WENT ON FLOW OF 2,5 LIT/MIN. AFTER SOME MINUTES, THE GRAFT STARTED LEAKING IN VISIBLE AND DANGEROUS WAY (JETS). THE SURGEONS DECIDED TO STOP THE ECLS ASSISTANCE BY WEANING OF THE CARDIOHELP IN ORDER TO EXPLANT THE GRAFT. THE PATIENT DID NOT SUPPORT THE WEANING OF THE ECLS MODE : HER HEART WENT INTO FIBRILLATION, ANOTHER GRAFT (FROM COMPETITION) WAS USED TO REPLACE THE INVOLVED GRAFT, THE ECMO PROCEDURE WAS RESTARTED. THE PATIENT DID NOT SUPPORT THE PROCESS AND DECEASED.

  Patient problems: Death

  MAUDE report 6201964 ↗

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 · Terminated
  HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; H