CARBOMEDICS OPTIFORM F7-033Recalls & reported problems
Corcym Srl · Class 3 · Implant
All models of CARBOMEDICS OPTIFORM (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08022057012883), received between Mar 7, 2021 and Mar 7, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Close” (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
Device problems
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2021Difficult to Open or Close; Difficult to Open or Close
ON 05 FEB 2021, A CARBOMEDICS OPTIFORM PROSTHESIS F7-033 WAS INTENDED AS PART OF A MITRAL VALVE REPLACEMENT PROCEDURE. THE PATIENT¿S PRE-OPERATIVE DIAGNOSIS WAS OF MITRAL VALVE ENDOCARDITIS. AFTER EXPOSURE OF THE MITRAL VALVE, THE ANTERIOR LEAFLET WAS EXCISED, WHILE THE POSTERIOR LEAFLET AND THE SUBVALVULAR APPARATUS WERE PRESERVED. THE PROSTHESIS WAS IMPLANTED IN ANTI-ANATOMICAL POSITION. AFTER WEANING FROM BYPASS, THE PROSTHESIS FUNCTIONALITY WAS CHECKED AT THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND AN INTERMITTENT BLOCKAGE OF THE POSTERIOR LEAFLET OF THE PROSTHESIS IN THE CLOSE POSITION WAS DETECTED. THE CROSS-CLAMP WAS RE-STARTED, AND THE VALVE WAS CHECKED. THE INSPECTION OF THE PROSTHESIS DID NOT FIND THE CAUSE OF THE LEAFLET BLOCKAGE. THERE WAS NO RESIDUAL CORD THAT COULD INTERFERE WITH THE OPENING OF THE VALVE. THE THREADS WERE CUT FLUSH. THE MOBILITY OF THE LEAFLETS WITH THE TESTER APPEARED NORMAL. THE PROSTHESIS WAS ROTATED TO THE ANATOMICAL POSITION. AFTER DE-CLAMPING, THE PROSTHESIS WAS CHECKED AGAIN AT THE TEE AND AN ASYNCHRONOUS MOBILITY OF THE LEAFLETS WAS DETECTED WITH A NEW BLOCKING WHEN CLOSING THE REAR LEAFLET. THE VALVE WAS ULTIMATELY EXPLANTED AND REPLACED WIT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11429731 ↗
Other HEART-VALVE, MECHANICAL devices
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- SJM Regent™ AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths70 reports
- SJM Regent™ AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL5 deaths66 reports
- SJM Regent™ 23AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths44 reports
- CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-021Corcym Srl · HEART-VALVE, MECHANICAL7 deaths37 reports
- Regent™ 21AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths35 reports
- Regent™ 23AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL2 deaths33 reports
- Regent™ 19AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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