CARBOMEDICS OPTIFORM F7-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08022057012838), received between Dec 20, 2017 and Feb 11, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2022Fracture; Fracture

  ON (B)(6) 2021, AN OPTIFORM SIZE 23 MITRAL VALVE WAS IMPLANTED. BASED ON THE INFORMATION RECEIVED, THE VALVE LEAFLET BROKE WHILE THE SURGEON WERE ROTATING THE VALVE. THE TOTAL DURATION OF THE SURGERY WAS MORE THAN 3 HOURS. THE PATIENT WAS STABLE DURING THE PROCEDURE AND IS RECOVERING. NO DEVICE MALFUNCTION WERE DETECTED PRIOR TO THE EVENT. AS REPORTED, THE VALVE WAS ROTATED WITH THE VALVE ROTATOR PROVIDED BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515575 ↗
• InjuryDec 20, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AN OPTIFORM PROSTHETIC MITRAL HEART VALVE F7-023 WAS EXPLANTED DUE TO PATIENT-PROSTHESIS MISMATCH. THE 23 MM OPTIFORM WAS REPORTEDLY TOO SMALL FOR THE PATIENT. THE VALVE WAS EXPLANTED AND A 25 MM ST. JUDE MECHANICAL VALVE WAS IMPLANTED. THE PATIENT HAD A NORMAL RECOVERY, AND WAS DISMISSED FROM THE HOSPITAL ON SCHEDULE. THERE WAS NO QA ISSUE WITH THE VALVE. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS.

  Patient problems: No Information

  MAUDE report 7135581 ↗