Hemagard HGK1809Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00384401014393), received between Oct 2, 2015 and May 3, 2019 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  AFTER ANASTOMOSIS OF PROXIMAL AND DISTAL ENDS, CLINICIAN REPORTED BLOOD WEEPING THROUGH BODY OF THE GRAFT ONCE THE CLAMPS WERE REMOVED. TWO CASES WERE REPORTED TOGETHER BY SAME CLINICIAN (SEE MANUFACTURER REPORT 1640201-2019-00027 FOR OTHER CASE). SURGEON ALLOWED THE BLOOD TO WEEP THROUGH THEN CLAMP FOR A FEW MINUTES TO ALLOW THE BLOOD TO COAGULATE TO GRAFT WALL THEN PROCEEDED WITH REST OF SURGERY. NO INDICATION OF ACTUAL OR POTENTIAL HARM OF PATIENT.

  Patient problems: Blood Loss

  MAUDE report 8578403 ↗
• InjuryJun 8, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING AN AORTO-BIFEMORAL PROCEDURE, PERFORMED ON (B)(6) 2017, IT WAS REPORTED THERE WAS A LOT OF BLEEDING DURING THE PROCEDURE . THE BLEEDING WAS STOPPED BY CLAMPING THE GRAFT. THE PATIENT HAD A LOW BLOOD PRESSURE, AND UNEXPECTED BLOOD TRANSFUSION WAS PERFORMED. IT WAS ALSO REPORTED THAT BEFORE THE AORTO-BIFEMORAL IMPLANTATION, A TEMPORARY AXILLOBIFEMORAL SHUNT WAS PERFORMED WITH ANOTHER GRAFT HGK0010-100 WITHOUT BLEEDING. NO CONSEQUENCE FOR THE PATIENT WAS REPORTED.

  Patient problems: Blood Loss

  MAUDE report 6621259 ↗
• InjuryMay 23, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING A SURGERY PERFORMED ON (B)(6) 2017, THE HOSPITAL REPORTED THAT THERE WAS AN EXCESSIVE LEAKING THROUGH THE GRAFT. THE PRODUCT REMAINED IMPLANTED. NO INFORMATION ABOUT THE CONSEQUENCE FOR PATIENT COULD BE OBTAINED AT THE DATE OF THIS REPORT.

  Patient problems: Blood Loss

  MAUDE report 6583792 ↗
• MalfunctionJun 13, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING AN EXTRAANATOMICAL BYPASS SURGERY PERFORMED ON (B)(6) 2016 FOR AN ABDOMINAL AORTIC ANEURYSMA, IT WAS REPORTED A BLEEDING THROUGH THE GRAFT. THE BLEEDING OCCURRED DURING SEWING THE ANASTOMOSIS AND STOPPED BY ITSELF AFTER WAITING NEARLY HALF AN HOUR. THE GRAFT REMAINED IMPLANTED. NO ADVERSE CONSEQUENCE FOR THE PATIENT HAS BEEN REPORTED.

  Patient problems: Blood Loss

  MAUDE report 5720234 ↗
• InjuryOct 2, 2015Improper or Incorrect Procedure or Method

  DURING A CARDIAC SURGERY, THE GRAFT WAS USED TO CONNECT THE FEMORAL ARTERY TO THE CARDIOPULMONARY BYPASS MACHINE. THE GRAFT WAS REPORTED TO LEAK FROM THE BODY ITSELF, WHICH REQUIRED THE USE OF HEMOSTATIC AGENT TO STOP THE BLEEDING BEFORE PROCEEDING WITH THE OPERATION. PATIENT HAD NO COMPLICATION. THE PRODUCT WAS DISCARDED AFTER USE.

  Patient problems: Blood Loss

  MAUDE report 5123644 ↗

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