Hemagard HGK0008-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384401014157), received between Aug 3, 2016 and Sep 27, 2016 — classified as 3 injuries.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 reports).

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.

• InjurySep 27, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING AN ILIOFEMORAL BYPASS PROCEDURE PERFORMED ON (B)(6) 2016, THERE WAS A LOT OF BLEEDING THROUGH THE GRAFT WALLS (MORE THAN "BLUSH") WHEN THE CLAMP WAS REMOVED. THE SURGEON HAD TO MANUALLY COAGULATE THE GRAFT WITH THE PATIENT BLOOD TO CONTROL THE BLEEDING, AND WORKED THE CLAMP OPEN AND CLOSED TO HELP TO COAGULATE AS WELL. THE GRAFT REMAINED IMPLANTED AND THE PATIENT WAS REPORTED AS BEING FINE.

  Patient problems: Blood Loss

  MAUDE report 5979327 ↗
• InjuryAug 4, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING A REDO AORTIC VALVE REPLACEMENT (AVR) PROCEDURE PERFORMED ON (B)(6) 2016, THE GRAFT WAS USED AS A CONDUIT FOR AXILLARY ARTERY CANNULATION. WHEN THE CLAMP WAS REMOVED, THERE WAS A LOT OF OOZING FROM THE GRAFT AND THE GRAFT HAD TO BE WRAPPED WITH A HEMOSTATIC AGENT. THE CASE WAS COMPLETED. NO ADVERSE OUTCOME FOR THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION ON THE PRODUCT SERIAL NUMBER COULD BE OBTAINED AT THE DATE OF THIS REPORT.

  Patient problems: Blood Loss

  MAUDE report 5846118 ↗
• InjuryAug 3, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING A FEMORO-FEMORAL BYPASS PROCEDURE PERFORMED ON (B)(6) 2016, THE PATIENT WAS ON EXTRACORPOREAL MEMBRANE OXYGENATION WITH AN INITIAL CANNULATION AT THE FEMORAL ARTERY LEVEL AND WAS REPORTED TO BE VERY SICK. THE SURGEON WANTED TO MOVE THE CANNULATION TO THE AXILLARY ARTERY AND HE USED FOR THAT THE INVOLVED HEMAGARD GRAFT. THE GRAFT WAS REPORTED TO LEAK A LOT AND THE BLEEDING COULD NOT BE CONTAINED. SO THE GRAFT COULD NOT BE LEFT IN PLACE AND THE CANNULATION WAS MOVED TO ITS INITIAL LOCALISATION. THE PROCEDURE WAS THEN COMPLETED AND THE GRAFT WAS DISCARDED. NO ADVERSE OUTCOME FOR THE PATIENT WAS REPORTED AFTER THE SURGERY. IT WAS AFTERWARDS REPORTED THAT THE PATIENT DECEASED AT A LATER DATE DUE TO OTHER CAUSES UNRELATED TO THIS INCIDENT.

  Patient problems: Blood Loss

  MAUDE report 5842775 ↗

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