CARBOMEDICS OPTIFORMRecalls & reported problems across all models

We found 6 models of CARBOMEDICS OPTIFORM by Corcym Srl in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2017 and Feb 11, 2026 — classified as 3 deaths, 22 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CARBOMEDICS OPTIFORM problems

CARBOMEDICS OPTIFORM models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CARBOMEDICS OPTIFORM F7-027

  HEART-VALVE, MECHANICAL
  3 deaths16 reports
• CARBOMEDICS OPTIFORM F7-029

  HEART-VALVE, MECHANICAL
  12 reports
• CARBOMEDICS OPTIFORM F7-025

  HEART-VALVE, MECHANICAL
  4 reports
• CARBOMEDICS OPTIFORM F7-023

  HEART-VALVE, MECHANICAL
  2 reports
• CARBOMEDICS OPTIFORM F7-031

  HEART-VALVE, MECHANICAL
  2 reports
• CARBOMEDICS OPTIFORM F7-033

  HEART-VALVE, MECHANICAL
  1 report

Recent CARBOMEDICS OPTIFORM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Difficult to Open or Close

  THE MANUFACTURER WAS NOTIFIED OF THE INTRAOPERATIVE EXPLANT OF A CARBOMEDICS OPTIFORM MITRAL IN SIZE 27. THE FOLLOWING PROVIDES A COMPREHENSIVE SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. AFTER THE VALVE WAS IMPLANTED, ON (B)(6) 2026, IT EXHIBITED A STICKING PHENOMENON DURING LEAFLET MOTION, IN WHICH THE LEAFLETS FAILED TO OPEN AND CLOSE SMOOTHLY. AN EMERGENCY IMPLANTATION OF ANOTHER VALVE OF THE SAME MODEL AND SIZE WAS CARRIED OUT, AND THE REMAINDER OF THE PROCEDURE PROCEEDED WITHOUT COMPLICATIONS. THE SURGERY WAS ULTIMATELY COMPLETED SUCCESSFULLY, WITH THE PATIENT REMAINING STABLE THROUGHOUT THE ADDITIONAL 40 MINUTES OF CROSS CLAMP AND BYPASS TIME REQUIRED DUE TO THE EVENT. THE PROCEDURE WAS PERFORMED BY AN EXPERIENCED SURGEON VIA FULL STERNOTOMY AS A STANDALONE SURGERY, WITH NO POSITIONING DIFFICULTIES, NO DEVICE MALPOSITIONING OR MISSIZING, AND NO ABNORMAL ANNULAR GEOMETRIES REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24311650 ↗
• MalfunctionFeb 10, 2026Difficult to Open or Close

  THE MANUFACTURER WAS NOTIFIED OF THE INTRAOPERATIVE EXPLANT OF A CARBOMEDICS OPTIFORM MITRAL VALVE IN SIZE 27. THE FOLLOWING PROVIDES A COMPREHENSIVE SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. ON (B)(6) 2025, DURING A MITRAL VALVE SURGERY USING THE CARBOMEDICS OPTIFORM MITRAL HEART VALVE, THE SURGEON DISCOVERED ON ECHO THAT ONE OF THE LEAFLETS WAS NOT OPENING PROPERLY. FURTHER ATTEMPTS STILL ENDED IN FAILURE, THEREFORE THE VALVE WAS REMOVED AND REPLACED WITH A MEDTRONIC HEART VALVE. THE ECHO SHOWED NORMAL FUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 24302364 ↗
• 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 ↗
• InjuryOct 17, 2025Difficult to Open or Close; Difficult to Open or Close

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH OPTIFORM POST-MARKET FOLLOW -UP STUDY. BASED ON THE INFORMATION RECEIVED, PATIENT UNDERWENT MITRAL ARTIFICIAL MECHANICAL VALVE REPLACEMENT AND TRICUSPID VALVULOPLASTY (FORMING RING) UNDER GENERAL ANESTHESIA AND CARDIOPULMONARY BYPASS ON (B)(6) 2019. NO ADHESION WAS OBSERVED IN THE CENTRAL PERICARDIUM DURING THE OPERATION. THE HEART WAS STOPPED BY RETROGRADE PERFUSION SURGERY. THE MITRAL VALVE WAS REMOVED WHILE PART OF THE POSTERIOR VALVE WAS RETAINED. 15 STITCHES WERE INTERMITTENTLY SUTURED AT THE MITRAL VALVE POSITION. AFTER VALVE MEASUREMENT, AN OPTIFORM VALVE SIZE 27 WAS INSERTED. EIGHT STITCHES WERE SUTURED AROUND THE TRICUSPID VALVE IN A MATTRESS MANNER. AFTER MEASURING THE VALVE, AN EDWARDS 4600/28MM FORMING RING WAS PLACED. THE ATRIAL SEPTUM AND THE RIGHT ATRIAL INCISION WERE CLOSED, THE AORTA WAS OPENED, AND THE ELECTROCARDIOGRAM AUTOMATICALLY RETURNED TO SINUS RHYTHM. THERE WAS NO ATRIOVENTRICULAR BLOCK AND ASSISTED CIRCULATION. THE SHUTDOWN WAS SMOOTH. AFTER THE OPERATION, THE PATIENT WAS RETURNED TO THE ICU FOR HEART RATE AND BLOOD PRESSURE MONITORING. AT THE SAME TIME, SYMPTOMATIC AND SUPPORTIVE TREATMENTS SUCH AS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23330567 ↗
• DeathAug 20, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2025, THE PATIENT UNDERWENT DOUBLE VALVE REPLACEMENT SURGERY VIA FULL STERNOTOMY DUE TO BOTH AORTIC AND MITRAL VALVE INSUFFICIENCY. THE AORTIC VALVE WAS FIRST SUCCESSFULLY REPLACED WITH A CARBOMEDICS TOP HAT VALVE, MODEL S5-021 (SN (B)(6). IN THE SAME PROCEDURE, MITRAL VALVE REPLACEMENT WAS INITIATED. THE NATIVE MITRAL LEAFLETS AND SUBVALVULAR CHORDS WERE COMPLETELY EXCISED. THE ANNULUS WAS SIZED USING THE DEDICATED SIZERS MODEL VS-200 WITHOUT ANY DIFFICULTY, AND A CARBOMEDICS OPTIFORM F7-27 VALVE WAS SELECTED FOR IMPLANTATION. FOLLOWING THE INITIAL IMPLANTATION OF THE F7-27, ECHOCARDIOGRAPHIC EVALUATION REVEALED HIGH-SPEED REGURGITANT FLOW WITHIN THE MITRAL VALVE. THE VALVE WAS REMOVED AND RE-IMPLANTED, BUT THE ABNORMAL FLOW PERSISTED. CONSEQUENTLY, THE F7-27 WAS REPLACED WITH A CARBOMEDICS OPTIFORM F7-025 VALVE (SN (B)(6), WHICH WAS IMPLANTED IN THE SAME POSITION. POST-IMPLANTATION IMAGING CONFIRMED THE DISAPPEARANCE OF THE REGURGITATION. THE EXTRACORPOREAL CIRCULATION TIME DURING THE SURGERY WAS 523 MINUTES, AND THE CROSS-CLAMP TIME WAS APPROXIMATELY 400 MINUTES. DUE TO THIS INCIDENT, THE CROSS-CLAMP TIME INCREASED BY ABOUT 150 MINUTES AND THE EXTRACORPOREAL CIRCULATIO

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22847276 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 27, 2024Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED ON 28 AUG 2024, AFTER SURGERY, IT WAS FOUND THROUGH ECHO THAT ONE OF THE LEAFLETS OF OPTIFORM SIZE 27 COULD NOT CLOSE AND THERE WAS REFLUX. AFTER REINSTALLING ANOTHER VALVE OF CORCYM, ECHO RETURNED TO NORMAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20323123 ↗
• 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 ↗
• MalfunctionJun 1, 2023Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, AFTER SIZING WITH CORCYM SIZER, OPTIFORM MITRAL VALVE SIZE 27 WAS IMPLANTED. REPORTEDLY, THE LEAFLET WAS STUCK AND DIFFICULT TO OPEN / CLOSE. AS SUCH, ANOTHER OPTIFORM VALVE SIZE 27 WAS IMPLANTED IN THE PATIENT. BASED ON THE FURTHER INFORAMTION RECEIVED, WHILE TESTING THE LEAFLET WITH A TESTER AFTER THE SUTURING WAS COMPLETED, THE BLOCKAGE WAS DETECTED. AS REPORTED, THERE WAS NO ABNORMAL GEOMETRY IN PATIENT'S ANATOMY AND NO CONCOMITANT PROCEDURE WAS PERFORMED. FURTHERMORE, NO ADDITIONAL DEBRIDEMENT OR ANNULAR RESTRUCTURING WAS PERFORMED PRIOR TO THE SECOND IMPLANT. REPORTEDLY, 30 MINUTES WAS ADDED TO THE PROCEDURE AS A RESULT OF THIS EVENT, AND PATIENT WAS STABLE THROUGH THE PROLONGATION OF SURGERY WITH A GOOD OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17043905 ↗
• MalfunctionMay 8, 2023Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT. ON (B)(6) 2023, WHEN IMPLANTING OPTIFORM PROSTHETIC HEART VALVE (F7-027), ONE LEAFLET WAS STUCK AND COULDN'T BE OPENED. AS SUCH, THE VALVE WAS EXPLANTED AND ANOTHER F7-027 WAS IMPLANTED IN THE PATIENT TO COMPLETE THIS PROCEDURE. REPORTEDLY, PATIENT WAS FINE AND STABLE. THE TEST ON THE EXPLANTED VALVE WAS PERFORMED AFTER EXPLANT AND THE LEAFLET HAD A STUCK ISSUE. BASED ON THE FURTHER INFORMATION RECEIVED, THORACIC SURGERY WAS PERFORMED TO PRESERVE THE SUBVALVULAR STRUCTURE. THE SUBVALVULAR STRUCTURE WAS OBSERVED AND DID NOT AFFECT VALVE OPENING AND CLOSING, AND THE VALVE WAS ALSO ROTATED. REPORTEDLY, NO ADDITIONAL DEBRIDEMENT OR RECONSTRUCTION WAS PERFORMED BEFORE IMPLANTING THE NEW VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892365 ↗
• InjuryFeb 23, 2023Fracture; Fracture

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT. ON (B)(6) 2022, DURING A MITRAL VALVE REPLACEMENT OPERATION, ONE LEAFLET OF 27MM CARBOMEDICS OPTIFORM VALVE WAS BROKEN DURING SUTURING. AS SUCH, THE VALVE WAS EXPLANTED AND CARBOMEDICS OPTIFORM SIZE 25 WAS IMPLANTED AS A REPLACEMENT. BASED ON THE FURTHER INFORMATION RECEIVED, THERE IS NO NEGATIVE OUTCOMES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16433388 ↗
• MalfunctionAug 26, 2022Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT. BEFORE IMPLANTING, THE SIZING WAS PERFORMED (USING CORCYM SIZER) WITH NO PROBLEM AND OPTIFORM PROSTHETIC MITRAL HEART VALVE F7-027 WAS CHOSEN TO BE IMPLANTED. THE VALVE WAS TESTED AND NO PROBLEM WAS IDENTIFIED. AFTER IMPLANTING THE VALVE, IT WAS DETECTED THAT THE OPENING/CLOSING OF THE VALVE LEAFLET WAS NOT SMOOTH. AS SUCH, THE VALVE WAS EXPLANTED AND ANOTHER F7-027 WAS PLANTED. REPORTEDLY, THE PROCEDURE WAS COMPLETED WELL, AND THE PATIENT OUTCOME IS FINE. BASED ON THE INFORMATION RECEIVED, ALMOST TOTAL RESECTION OF THE NATIVE VALVE WAS PERFORMED, BUT SOME CHORDAE PAPILLARY MUSCLE WERE KEPT. REPORTEDLY, THERE WAS NO ABNORMAL PATIENT GEOMETRIES AND NO CONCOMITANT PROCEDURE WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306951 ↗

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