Hemagard HGK0008-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384401014133), received between Feb 24, 2016 and Nov 21, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CONCERNED GRAFT WAS USED AS AN EXTRACORPOREAL VESSEL CHANNEL. THE GRAFT LEAKED DURING SURGERY. PATIENT ENDANGERED BUT NOT INJURED.

  Patient problems: Blood Loss

  MAUDE report 8093977 ↗
• InjuryNov 22, 2017Break; Break

  DURING AN ILIO-ILIAC BYPASS SURGERY PERFORMED ON (B)(6) 2017, IT WAS REPORTED THAT THE GRAFT WAS CUT OFF TO ADAPT TO THE ANATOMICAL CONDITIONS. WHEN INSERTING INTO THE ANASTOMOSIS, THE GRAFT CRACKED. ANOTHER HGK0008-20 GRAFT WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY 10 MIN AND ENDED REGULARLY. IT WAS REPORTED THAT THE CURRENT STATUS OF THE PATIENT WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7052968 ↗
• InjuryFeb 24, 2016Leak/Splash

  DURING AN ASCENDING ANEURYSM REPAIR PERFORMED ON (B)(6) 2016, THE GRAFT WAS USED FOR AXILLARY CANNULATION. ONCE HEPARIN WAS GIVEN, THE GRAFT LEAKED MORE THAN WHAT THE SURGEON USED TO. IT WAS REPORTED THAT AN INTERVENTION WAS REQUIRED TO PREVENT SERIOUS INJURY BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THE TIME OF THIS REPORT. THE DEVICE WAS DISCARDED AFTER THE PROCEDURE, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5457137 ↗

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-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
• 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