CARBOMEDICS ORBIS M2-027Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08022057012548), received between Oct 8, 2018 and Oct 8, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (1 report).

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

• InjuryOct 8, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  ON (B)(6) 2018 AN ORBIS M2-027 MECHANICAL MITRAL VALVE WAS IMPLANTED. IT WAS REPORTED THAT AFTER ONE HOUR ONE OF THE LEAFLETS STOPPED MOVING AS OBSERVED BY ECHO. THE VALVE WAS EXPLANTED AND A SECOND ORBIS M2-027 WAS IMPLANTED. NO CONCOMITANT PROCEDURES WERE PERFORMED. THE PATIENT HAD NO ABNORMAL GEOMETRIES AND AFTER THE REDO PROGRESSED WELL WITH RECOVERY.

  Patient problems: No Information

  MAUDE report 7942498 ↗