Hemapatch HEK25/100P (1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384401001591), received between Nov 25, 2016 and Nov 25, 2016 — classified as 1 injury.

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

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE INVOLVED PATCH WAS USED TO AUGMENT THE AORTIC ROOT AND ASCENDING AORTA IN THE CONTEXT OF AN OPERATION TO REPAIR SUPRA-VALVULAR AORTIC STENOSIS AND TO REPAIR THE AORTIC VALVE. AFTER REPERFUSING THE AORTIC ROOT, THERE WAS SEVERE BLEEDING THROUGH THE INTERSTICES OF THE PATCH, IN ADDITION TO SOME EXPECTED NEEDLE HOLE BLEEDING FROM THE SUTURE LINE. AFTER THE VISUAL INSPECTION OF THE ENTIRE SUTURE LINE, NO SURGICAL DEFECT AND NO SURGICAL BLEEDING WERE CONFIRMED. PROTAMINE WAS ADMINISTRATED TO STOP THE PATCH LEAKAGE AS WELL AS THE SUTURE LINE NEEDLE HOLE BLEEDING. HOWEVER, SEVERE BLOOD LEAK THROUGH THE PATCH INTERSTICES PERSISTED, DESPITE ADEQUATE REVERSAL OF HEPARIN AND ADMINISTRATION OF CLOTTING FACTORS (FRESH FROZEN PLASMA, PLATELETS, FIBRINOGEN, AND VARIOUS COAGULATION FACTORS). MOST OF THE BLEEDING CONTINUED THROUGH THE FABRIC PATCH ITSELF RATHER THAN THE SUTURE LINE, LIKELY BECAUSE OF THE LARGER SURFACE AREA OF THE PATCH. THE BLEEDING WAS SO SEVERE AND PERSISTENT THAT CONTINUOUS TRANSFUSION WAS NECESSARY TO MAJOR HEMODYNAMIC INSTABILITY. ONLY OPTION LEFT TO SAVE THE PATIENT LIFE WAS TO RESUME HYPOTHERMIC CARDIOPULMONARY BYPASS, CROSS CLAMP THE AORTA AND ARREST THE HEART WITH CAR

  Patient problems: Blood Loss

  MAUDE report 6127161 ↗

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