Coseal Surgical Sealant 934071Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05413765404627), received between Apr 9, 2024 and Jul 2, 2024 — classified as 2 injuries.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 6, 2023Class IIOpen, Classified

   Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

   Z-0657-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIVE DAYS PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT UNDERWENT A THORACOTOMY (PULMONARY ARTERY BANDING) PROCEDURE WHEREIN COSEAL SURGICAL SEALANT WAS APPLIED. THREE DAYS LATER THE PATIENT DEVELOPED A TWO-STAGE PULSE ARRHYTHMIA UPON AWAKENING. ANALGESIA WAS ADDED AND THE PATIENT WAS MONITORED. CIRCULATION WAS STABLE. TWO DAYS LATER SEDATION WAS TERMINATED AND THE TWO STAGE PLUSE DID NOT REOCCUR. THE FOLLOWING DAY THE PATIENT WAS TRANSFERRED TO A GENERAL MEDICAL UNIT. AN ECHOCARDIOGRAM WAS PERFORMED, AND A SMALL AMOUNT OF PERICARDIAL FLUID WAS FOUND AROUND THE ENTIRE CIRCUMFERENCE OF THE HEART. DIASTOLIC DIMENSION IS LESS THAN 1MM. TWO DAYS AFTER THAT, A FOLLOW UP ECHOCARDIOGRAM WAS PERFORMED, AND A PERICARDIAL EFFUSION WAS OBSERVED AROUND THE ENTIRE HEART. THE DIASTOLIC DIMENSION WAS ABOUT 7 MM, WHICH HAD RAPIDLY INCREASED COMPARED TO THE DAY BEFORE YESTERDAY. EMERGENCY DRAINAGE WAS PERFORMED. A MEDIAN SUBCUTANEOUS INCISION OF ABOUT 4 CM WAS MADE TO REACH THE PERICARDIAL SAC AT THE DIAPHRAGMATIC PLANE, RESULTING IN A CLEAR RED PALE BLOODY PERICARDIAL EFFUSION. THE PERICARDIAL EFFUSION DRAINED APPROXIMATELY 35 ML. SINCE THERE WAS NO PERSISTENT BLEEDING IN THE PERICARDIAL SAC, A

  Patient problems: Cardiac Tamponade

  MAUDE report 19657698 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A PULMONARY ARTERY BANDING WHEREIN COSEAL SURGICAL SEALANT WAS APPLIED UTILIZING EASYSPRAY AND COSEAL SPRAY SET. THE PATIENT WAS ADMITTED TO THE PEDIATRIC INTENSIVE CARE UNIT. FOUR DAYS POSTOPERATIVE (POSTOP) AN ECHOCARDIOGRAM WAS PERFORMED, AND NO ABNORMALITIES WERE NOTED. BOTH THE INTRAPERICARDIAL AND MEDIASTINAL DRAINS WERE REMOVED. THE PATIENT WAS TRANSFERRED TO A GENERAL MEDICAL PEDIATRIC UNIT IN ¿STABLE CONDITION.¿ THE FOLLOWING DAY, AT 0100 SERUM EXUDATE WAS OBSERVED ORIGINATING FROM THE WOUND. TWO HOURS LATER, AN ECHOCARDIOGRAPHY SHOWED A SMALL AMOUNT OF PERICARDIAL FLUID ALL AROUND THE WOUND. THERE WAS A ¿POSSIBILITY OF LEAKING FLUID FROM THE SUTURE GAP IN THE WOUND;¿ HOWEVER, THE WOUND EDGE WAS NOT BROKEN OPEN AND WAS TEMPORARILY PROTECTED WITH A DRESSING AND FILM.¿ PREDONINE WAS STARTED AS ¿PERICARDIAL FLUID THERAPY.¿ SEVEN HOURS LATER, AN ECHOCARDIOGRAPHY SHOWED INCREASED PERICARDIAL EFFUSION AROUND THE ENTIRE CIRCUMFERENCE (DIASTOLIC 1.5-2.0 MM, SYSTOLIC 3.5 MM [UP TO 6 MM IN SOME AREAS]). SIX AND HALF HOURS LATER THE ECHOCARDIOGRAPHY WAS REEVALUATED, AND THE DETERIORATION WAS ASSESSED. THE PATIENT WAS DIAGNOSED WITH CARDIAC TAMPONADE DUE TO PERIC

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 19071312 ↗