Hemagard HGK0010-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401014225), received between Sep 29, 2016 and Nov 21, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Hole In Material” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K964625); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING A BEDSIDE ECMO CANNULATION PROCEDURE PERFORMED ON (B)(6) 2017 IN THE CARDIAC ICU INTERVENTION, BLOOD LEAKING OCCURRED WHILE HEMAGARD 10 MM KNITTED GRAFT WAS USED AS A CANNULA. THE GRAFT WAS USED AS A CONDUIT AS AN ACCESSORY TO PASS THE BLOOD. THE BLOOD LEAKING WAS STOPPED BY ADDING FACTORS SUCH AS FFP AND A PACKING AND WRAPPING OF THE GRAFT. BLOOD TRANSFUSION WAS REQUIRED AND THE INTERVENTION WAS LONGER THAN EXPECTED. THE GRAFT WAS NOT AVAILABLE FOR INVESTIGATION AS IT WAS TOSSED OUT AFTER THE PROCEDURE BECAUSE IT WAS USED EXTERNALLY AS A CONDUIT. IT WAS REPORTED THAT THE PATIENT WAS VERY SICK AND HAD A SEVERE CARDIOMYOPATHY. IT WAS ALSO REPORTED THAT THE PATIENT DIED ON (B)(6) 2017 DUE TO OTHER CAUSES, NOT RELATED TO THE HEMAGARD GRAFT EVENT.

  Patient problems: Blood Loss

  MAUDE report 7048347 ↗
• InjurySep 29, 2016Hole In Material; Hole In Material

  DURING A SURGERY PERFORMED ON (B)(6) 2016, A SMALL SOURCE OF BLEEDING WAS NOTED IN THE GRAFT. THE SURGEON HAD TO PLACE AN ADDITIONAL STITCH TO CLOSE THE HOLE IN THE GRAFT TO ACHIEVE HEMOSTASIS. THE GRAFT REMAINED IMPLANTED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE SURGEON INDICATED THAT THE PUNCTURE COULD HAVE BEEN CAUSED BY A CLAMP OR OTHER SURGICAL INSTRUMENTS DURING IMPLANTATION. HE STATED THAT HE DID NOT FEEL THE EVENT WAS A FAILURE OF THE GRAFT.

  Patient problems: Blood Loss

  MAUDE report 5986452 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964625. One submission often covers many models, so check the product and lot details in each record.

• Z-1427-2010 · Dec 9, 2009 · Terminated
  InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in th
• Z-1439-2010 · Dec 9, 2009 · Terminated
  InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K9842