Biocor™ B100-33M-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734055468), received between Oct 23, 2019 and Jun 30, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Backflow” (2 reports).

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.

• InjuryJun 30, 2021Backflow; Incomplete Coaptation; Backflow; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 33MM BIOCOR STENTED PORCINE VALVE W/ FLEXFIT SYSTEM WAS SELECTED FOR IMPLANT. THE DEVICE WAS SUCCESSFULLY IMPLANTED AND THE PATIENT WAS TAKEN OFF OF BYPASS. POST-IMPLANT ECHO WAS PERFORMED AND SHOWED MORE MITRAL REGURGITATION THAN USUAL AND A POSSIBLE PROLAPSE OF THE LEAFLET. THE PATIENT WAS PLACED BACK ON BYPASS AND THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER 33MM BIOCOR STENTED PORCINE VALVE W/ FLEXFIT SYSTEM TO RESOLVE THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE WITH NO CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096699 ↗
• InjuryFeb 24, 2020Backflow; Incomplete Coaptation; Backflow; Incomplete Coaptation

  ON (B)(6) 2020. A 33MM BIOCOR VALVE WAS IMPLANTED. POST IMPLANT AN ECHOCARDIOGRAM WAS PERFORMED AND INCOMPLETE COAPTATION AND REGURGITATION WAS REPORTED. PRIOR TO CLOSING THE PATIENT THE VALVE WAS WORKING NORMALLY. THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A 33MM EPIC VALVE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Regurgitation

  MAUDE report 9746064 ↗
• InjuryOct 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2017, A 33 MM BIOCOR VALVE WAS IMPLANTED. THE PATIENT WAS SYMPTOMATIC AND PRESENTED WITH MITRAL REGURGITATION. ON (B)(6) 2019, THE VALVE WAS EXPLANTED WHERE A TEAR WAS OBSERVED AND REPLACED WITH A 31 MM MASTERS VALVE.

  Patient problems: Mitral Regurgitation

  MAUDE report 9224801 ↗