CARBOMEDICS OPTIFORM F7-029Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08022057012869), received between Apr 16, 2019 and Nov 21, 2025 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT REGISTRATION FORMS, A CARBOMEDICS OPTIFORM MITRAL VALVE F7-029 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2024. AFTER ABOUT 1 YEAR, THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE, BUT A SMALLER SIZE F7-027 ON (B)(6) 2025. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE SITE ABOUT ANY DEVICE DYSFUNCTION OR ADVERSE PATIENT OUTCOME AT THIS TIME.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Thrombosis/Thrombus

  MAUDE report 23613644 ↗
• InjuryNov 21, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT REGISTRATION FORMS, A CARBOMEDICS OPTIFORM MITRAL VALVE F7-029 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2024. AFTER ABOUT 1 YEAR, THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE, BUT A SMALLER SIZE F7-027 ON (B)(6) 2025. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE SITE ABOUT ANY DEVICE DYSFUNCTION OR ADVERSE PATIENT OUTCOME AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 23613630 ↗
• InjuryMay 15, 2025Fracture; Fracture

  THE MANUFACTURER WAS INFORMED OF A LEAFLET BREAKAGE OCCURRED ON (B)(6) 2025, WHILE IMPLANTING A CARBOMEDICS OPTIFORM MITRAL MECHANICAL VALVE F7-029. REPORTEDLY, DURING A MITRAL VALVE REPLACEMENT VIA FULL STERNOTOMY, ONE OF THE VALVE'S LEAFLETS FRACTURED FOLLOWING THE PARACHUTING MANEUVER AND WHILE THE PROSTHESIS WAS BEING SUTURED INTO PLACE. IT WAS ALSO CONFIRMED THAT A ROTATOR WAS USED TO ROTATE THE PROSTHESIS. THE DAMAGED MECHANICAL VALVE WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER PROSTHESIS OF THE SAME MODEL AND SIZE. AS REPORTED, THE PATIENT WAS NOT AFFECTED BECAUSE OF THE EVENT AND THE PROCEDURE WAS COMPLETED WITH A GOOD PATIENT'S OUTCOME. THE BROKEN PROSTHESIS WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND IT WAS RECEIVED ON 30 APRIL 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028436 ↗
• MalfunctionAug 4, 2024Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  MANUFACTURER WAS INFORMED THAT ON 5 JULY 2024, A CARBOMEDICS OPTIFORM VALVE SIZE 29 WAS PLANNED TO BE IMPLANTED. REPORTEDLY, WHILE REMOVING THE HOLDER AND PREPARING THE VALVE FOR IMPLANT, IT WAS NOTED THAT THE VALVE HAS ONLY ONE LEAFLET. BASED ON THE FURTHER INFORMATION RECEIVED, AFTER CONNECTED THE SUTURE WITH SEWING CUFF, THE SUTURE LOCK WAS CUT AND THAT IS WHEN THE MISSING LEAFLET WAS NOTED. AS SUCH, THE VALVE WAS REMOVED AND ANOTHER CARBOMEDICS OPTIFORM F7-029 WAS IMPLANTED INSTEAD. DEVICE BOX WAS CHECKED, BUT NO LEAFLET WAS FOUND. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19902568 ↗
• MalfunctionAug 22, 2023Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED THAT F7-029 VALVE WAS IMPLANTED IN THE PATIENT ON (B)(6)2023. REPORTEDLY, THE TEE AND ECHO IMAGES SHOWED THAT ONE LEAFLET COULDN'T BE CLOSED, ALONG WITH PVL. AS SUCH, THE VALVE WAS EXPLANTED, AND SMALLER VALVE (F7-027) WAS IMPLANTED TO COMPLETE THIS PROCEDURE SINCE NO MORE F7-029 WAS AVAILABLE. AFTER THE PROCEDURE, THE PATIENT OUTCOME IS FINE. REPORTEDLY, NO MALFUNCTION WITH THE DEVICE WAS NOTED PRIOR TO THIS EVENT. AS REPORTED, NO SUB-VALVULAR APPARATUS WAS PRESERVED, A DEBRIDEMENT SURGERY WAS PERFORMED PRIOR TO THE IMPLANT OF SECOND VALVE. REPORTEDLY, BEFORE IMPLANTING THE SECOND VALVE (F7-027), THE FIRST VALVE(F7-029) WAS ROTATED SEVERAL TENS OF ANGLES, BUT THERE WAS STILL ONE LEAF THAT WAS NOT CLOSING. FURTHERMORE, PATIENT WAS STABLE THROUGH THE PROLONGATION OF SURGERY.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17600151 ↗
• MalfunctionApr 22, 2022Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED OF THE DYSFUNCTION THAT NOTICED WITH THE LEAFLETS OF THE OPTIFORM VALVE. AS REPORTED, THE MITRAL VALVE AND CALCIFIED TISSUE WERE TRIMMED. AFTER THE IMPLANTATION OF THE OPTIFORM VALVE SIZE 29, IT WAS NOTICED THAT THE LEAFLETS WERE STUCK. THE VALVE WAS REMOVED. AFTER THE EXPLANT, THE LEAFLETS STILL WERE NOT MOVING AND DURING CHECKING THE VALVE ONE OF THE LEAFLETS BROKE AND FELL OFF. ANOTHER OPTIFORM VALVE (SAME MODEL) WAS IMPLANTED IN THE PATIENT AS A REPLACEMENT. AS REPORTED, THE OPERATION WAS SUCCESSFULLY COMPLETED, THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190545 ↗
• InjuryNov 5, 2020Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER HAS RECEIVED A CUSTOMER COMPLAINT ABOUT A CARBOMEDICS OPTIFORM MITRAL VALVE SIZE 29 (F7-029). IT WAS REPORTED THAT THE VALVE WOULD NOT OPEN PROPERLY AFTER IMPLANTATION AND WAS SUBSTITUTED WITH A SIZE 27. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT WENT FOR SURGERY DUE TO SUBVALVULAR STENOSIS AND MITRAL INSUFFICIENCY. AFTER IMPLANTATION OF THE F7-029 AND WEANING FROM BYPASS, ONE LEAFLET OF THE F7-029 DID NOT OPEN. BYPASS WAS RE-STARTED AND AFTER REOPENING, THE INSPECTION OF VALVE SHOWED NO FAILURES. AFTER TURNING THE VALVE, REVISING BULGY AREAS TO PREVENT VALVE LEAFLET OBSTRUCTION, THE PATIENT CAME OFF PUMP BUT STILL ONE LEAFLET DID NOT OPEN. THE BYPASS WAS RESTARTED AGAIN, AND THE F7-029 WAS REPLACED WITH THE SMALLER SIZE F7-027. THE VALVE FUNCTIONED WELL. CLOSING. THE PATIENT STARTED LEAKING FROM THE OLD FREESTYLE GRAFT, RE-SURGERY, AV BLOCK, CARDIAC MASSAGE, AV- RUPTURE, ECMO, ISCHEMIA, CARDIAC SYNDROME, ICU NEURAL INFARCTS, BLEEDING. THE PATIENT PASSED AWAY ON (B)(6) 2020 (AS REPORTED, NEITHER VALVES WERE SUSPECTED AS CONTRIBUTORY CAUSE OF THE PATIENT'S DEATH).

  Patient problems: Mitral Valve Stenosis

  MAUDE report 10796579 ↗
• InjuryNov 5, 2020Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER HAS RECEIVED A CUSTOMER COMPLAINT ABOUT A CARBOMEDICS OPTIFORM MITRAL VALVE SIZE 29 (F7-029). IT WAS REPORTED THAT THE VALVE WOULD NOT OPEN PROPERLY AFTER IMPLANTATION AND WAS SUBSTITUTED WITH A SIZE 27. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT WENT FOR SURGERY DUE TO SUBVALVULAR STENOSIS AND MITRAL INSUFFICIENCY. AFTER IMPLANTATION OF THE F7-029 AND WEANING FROM BYPASS, ONE LEAFLET OF THE F7-029 DID NOT OPEN. BYPASS WAS RE-STARTED AND AFTER REOPENING, THE INSPECTION OF VALVE SHOWED NO FAILURES. AFTER TURNING THE VALVE, REVISING BULGY AREAS TO PREVENT VALVE LEAFLET OBSTRUCTION, THE PATIENT CAME OFF PUMP BUT STILL ONE LEAFLET DID NOT OPEN. THE BYPASS WAS RESTARTED AGAIN, AND THE F7-029 WAS REPLACED WITH THE SMALLER SIZE F7-027. THE VALVE FUNCTIONED WELL AND THE PROCEDURE WAS COMPLETED. THE PATIENT STARTED LEAKING FROM THE OLD FREESTYLE GRAFT, THUS RE-SURGERY WAS PERFORMED. THESE EVENTS FOLLOWED: AV BLOCK, CARDIAC MASSAGE, AV- RUPTURE, ECMO, ISCHEMIA, CARDIAC SYNDROME, ICU NEURAL INFARCTS, BLEEDING. THE PATIENT PASSED AWAY ON (B)(6) 2020 (AS REPORTED, NEITHER VALVES WERE SUSPECTED AS CONTRIBUTORY CAUSE OF THE PATIENT'S DEATH). BASED ON THE MEDICAL JUDGMENT RE

  Patient problems: Mitral Valve Stenosis

  MAUDE report 10796468 ↗
• InjurySep 14, 2019Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2019, A PATIENT RECEIVED A CARBOMEDICS OPTIFORM F7-029 IN MITRAL POSITION. THE LEAFLETS WERE TESTED AFTER THE IMPLANT AND NO ISSUE WAS IDENTIFIED AT THAT TIME. AT THE END OF THE PROCEDURE, NORMAL VALVE FUNCTION WAS OBSERVED. HOWEVER, LATER IN THE AFTERNOON, AT THE ULTRASOUND IT WAS NOTICED THAT ONE OF THE LEAFLETS WAS NOT CLOSING PROPERLY THUS RESULTING IN REGURGITATION FROM THE SIDE OF THE LEAFLET. IT WAS CONSEQUENTLY DECIDED TO PERFORM A REOPERATION. DURING THE RE-DO SURGERY, NO IMPEDIMENT TO THE LEAFLET MOBILITY WAS IDENTIFIED. THE OPTIFORM F7-029 WAS EXPLANTED AND REPLACED WITH A ST. JUDE VALVE SIZE 29. THE PATIENT'S CONDITIONS AFTER THE RE-INTERVENTION ARE REPORTEDLY GOOD. BEFORE EXPLANTING OF THE CARBOMEDICS VALVE, THE PATIENT HAD HEMATURIA, AND THE HEMATURIA DISAPPEARED AFTER THE VALVE REPLACEMENT.

  Patient problems: Mitral Regurgitation

  MAUDE report 9056926 ↗
• InjurySep 13, 2019Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2019, A PATIENT RECEIVED A CARBOMEDICS OPTIFORM F7-029 IN MITRAL POSITION. THE LEAFLETS WERE TESTED AFTER THE IMPLANT AND NO ISSUE WAS IDENTIFIED AT THAT TIME. AT THE END OF THE PROCEDURE, NORMAL VALVE FUNCTION WAS OBSERVED. HOWEVER, LATER IN THE AFTERNOON, AT THE ULTRASOUND IT WAS NOTICED THAT ONE OF THE LEAFLETS WAS NOT CLOSING PROPERLY THUS RESULTING IN REGURGITATION FROM THE SIDE OF THE LEAFLET. IT WAS CONSEQUENTLY DECIDED TO PERFORM A REOPERATION. DURING THE RE-DO SURGERY, NO IMPEDIMENT TO THE LEAFLET MOBILITY WAS IDENTIFIED. THE OPTIFORM F7-029 WAS EXPLANTED AND REPLACED WITH A ST. JUDE VALVE SIZE 29. THE PATIENT'S CONDITIONS AFTER THE RE-INTERVENTION ARE REPORTEDLY GOOD. BEFORE EXPLANTING OF THE CARBOMEDICS VALVE, THE PATIENT HAD HEMATURIA, AND THE HEMATURIA DISAPPEARED AFTER THE VALVE REPLACEMENT.

  Patient problems: Mitral Regurgitation

  MAUDE report 9050778 ↗
• InjuryJun 10, 2019Difficult to Open or Close; Difficult to Open or Close

  A CARBOMEDICS OPTIFORM MITRAL VALVE WAS IMPLANTED. AFTER REMOVING THE CROSS-CLAMP, ECHO REVEALED THAT THE LEAFLETS WERE STUCK. CROSS-CLAMP WAS RESUMED, THE VALVE WAS ROTATED 90 DEGREES, AND THE LEAFLETS WERE TESTED. AFTER COMING OFF PUMP, INITIALLY THE VALVE APPEARED FUNCTIONAL; HOWEVER, THE DYSFUNCTION RECURRED. 2 HOURS POST-OPERATIVELY, THE DYSFUNCTION WAS REPORTEDLY RESOLVED WITH HEPARIN. IT WAS ALSO REPORTED THAT THE PATIENT'S HEART WAS MUSCULAR, AND MAY HAVE AFFECTED THE BLOOD FLOW.

  Patient problems: No Information

  MAUDE report 8685468 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 A PATIENT RECEIVED AN OPTIFORM F7-029 MECHANICAL MITRAL VALVE. THE MANUFACTURER WAS NOTIFIED THAT DURING THE PROCEDURE THE DEVICE WAS EXPLANTED AND REPLACED WITH A SMALLER OPTIFORM F7-027. A CONCOMITANT CARBOMEDICS S5-021 AORTIC VALVE WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 8520956 ↗