CARBOMEDICS OPTIFORM F7-031Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08022057012876), received between Feb 11, 2019 and Feb 5, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Leak/Splash1
Patient problems
- Mitral Valve Insufficiency/ Regurgitation1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2025Leak/Splash; Leak/Splash
THE MANUFACTURER WAS INFORMED THAT A CARBOMEDICS OPTIFORM MITRAL MECHANICAL PROSTHESIS SIZE 31 (F7-031) WHICH HAD BEEN IMPLANTED ON (B)(6) 2023, WAS EXPLANTED ON (B)(6) 2024 DUE TO A SIGNIFICANT LEAK AT THE HINGE OF THE VALVE. DURING THE INITIAL SURGERY CABG (4 VESSELS) HAD BEEN PERFORMED AS CONCOMITANT PROCEDURE. REPORTEDLY, THE INVOLVED PROSTHESIS WAS REPLACED WITH A NEW F7-031 PROSTHESIS. NO FURTHER INFORMATION IS AVAILABLE TO THE MANUFACTURER AT THE TIME OF THE PRESENT REPORT.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 21317651 ↗InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO OPTIFORM PROSTHETIC MITRAL HEART VALVE F7-031; IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH ANOTHER SIMILAR DEVICE, SAME SIZE F7-031 ON (B)(6) 2015. NO FURTHER EVENT DETAILS WERE PROVIDED AND VALVE WAS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Information
MAUDE report 8329750 ↗
Other HEART-VALVE, MECHANICAL devices
- On-X Mitral Heart Valve with Conform-X Sewing Ring ONXMC-25/33On-X Life Technologies, Inc. · Heart-Valve, Mechanical1 recall1 death34 reports
- 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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