CARBOMEDICS OPTIFORM F7-027Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08022057012852), received between Aug 10, 2017 and Feb 11, 2026 — classified as 3 deaths, 7 injuries, 6 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 16 most recent of 16 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• DeathOct 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 THE PATIENT UNDERWENT AORTIC AND MITRAL VALVE REPLACEMENT WITH CORCYM DEVICES DUE TO LESIONS ON BOTH VALVES. THE PATIENT RECEIVED AN OPTIFORM SIZE 27 IN MITRAL POSITION AND A TOP HAT SIZE 21 IN AORTIC POSITION. THE DEVICES WERE SAFELY IMPLANTED DURING THE SURGERY AND PATIENT DID WELL DURING SURGERY. THERE WAS NO ABNORMALITY OR MALFUNCTION NOTED ON THE VALVE DURING SURGERY. THE VALVES WERE TESTED AFTER IMPLANTATION AND CONFIRMED THE POSITION AND OPENING AND CLOSING FUNCTION WAS GOOD. AFTER THE OPERATION, THE HEART RATE AND BLOOD PRESSURE WERE STABLE, SO THE PATIENT WAS THEN TRANSFERRED TO ICU FOR OBSERVATION. TWO HOURS POST-OPERATION, THE PATIENT HAD A SUDDEN LOSS OF BLOOD PRESSURE (BLOOD PRESSURE 0), BUT THE HEARTBEAT REMAINED. THEN, THE PATIENT DIED. THE EMERGENCY ULTRASOUND SHOWED INADEQUATE OPENING AND CLOSING MOTION FOR S5 VALVE. SINCE NO FURTHER INVESTIGATION ON THE PATIENT WAS POSSIBLE, THE SITE COULD NOT ASSESS THE RELATIONSHIP BETWEEN THE DEVICES AND THE EVENT, NOR IF THE DEVICES MALFUNCTIONED OR NOT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12598202 ↗
• DeathOct 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 THE PATIENT UNDERWENT AORTIC AND MITRAL VALVE REPLACEMENT WITH CORCYM DEVICES DUE TO LESIONS ON BOTH VALVES. THE PATIENT RECEIVED AN OPTIFORM SIZE 27 IN MITRAL POSITION AND A TOP HAT SIZE 21 IN AORTIC POSITION.THE DEVICES WERE SAFELY IMPLANTED DURING THE SURGERY AND PATIENT DID WELL DURING SURGERY. THERE WAS NO ABNORMALITY OR MALFUNCTION NOTED ON THE VALVE DURING SURGERY. THE VALVES WERE TESTED AFTER IMPLANTATION AND CONFIRMED THE POSITION AND OPENING AND CLOSING FUNCTION WAS GOOD. AFTER THE OPERATION, THE HEART RATE AND BLOOD PRESSURE WERE STABLE, SO THE PATIENT WAS THEN TRANSFERRED TO ICU FOR OBSERVATION. TWO HOURS POST-OPERATION, THE PATIENT HAD A SUDDEN LOSS OF BLOOD PRESSURE (BLOOD PRESSURE 0), BUT THE HEARTBEAT REMAINED. THEN, THE PATIENT DIED. THE EMERGENCY ULTRASOUND SHOWED INADEQUATE OPENING AND CLOSING MOTION FOR S5 VALVE. SINCE NO FURTHER INVESTIGATION ON THE PATIENT WAS POSSIBLE, THE SITE COULD NOT ASSESS THE RELATIONSHIP BETWEEN THE DEVICES AND THE EVENT, NOR IF THE DEVICES MALFUNCTIONED OR NOT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12598198 ↗
• InjuryApr 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020 A PATIENT RECEIVED A CARBOMEDICS OPTIFORM F7-027 MECHANICAL HEART VALVE AS PART OF AN MVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A CARBOMEDICS STANDARD M7-031 MECHANICAL HEART VALVE. THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION FROM THE SITE IDENTIFYING THE FOLLOWING. THE OPTIFORM THROMBOSIS OCCURRED IN THE CONTEXT OF APPARENTLY THERAPEUTIC INR (2.5). AT THE TIME OF REOPERATION, THE DEVICE WAS COVERED IN A THIN FILM OF PALE WHITE THROMBUS (POSSIBLY FIBRIN). THIS WAS COMPLETELY CLEANED OFF IN SITU SO THE LEAFLETS COULD BE TESTED AND FREELY MOBILE WITHOUT RESTRICTIONS. FOLLOWING NEUTRALIZATION OF THE HEPARIN WITH PROTAMINE, THE DEVICE CLOTTED OFF AGAIN IN THE OPERATING ROOM. RETURNED BACK ON PUMP WITH HEPARIN AND REPLACED THE MITRAL VALVE WITH A STANDARD DEVICE (LARGER SIZE). NO ISSUES THIS TIME. PATIENT IS ALIVE AND WELL WITH THROMBOSIS SERVICE AIMING FOR HIGHER INR. (PT WAS A DOUBLE VALVE CASE WITH AORTIC VALVE REPLACEMENT DONE AT INITIAL SURGERY). PATHOLOGY IDENTIFIED THROMBUS ON DEVICE. NO MECHANICAL COMMENTS MADE. IT WAS IDENTIFIED BY THE PATIENTS FAMILY THAT THE PATIENT NEVER BRUISED AS A CHILD FROM INJUR

  Patient problems: No Information; Thrombosis

  MAUDE report 9914536 ↗
• InjuryApr 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020 A PATIENT RECEIVED A CARBOMEDICS OPTIFORM F7-027 MECHANICAL HEART VALVE AS PART OF AN MVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A CARBOMEDICS STANDARD M7-031 MECHANICAL HEART VALVE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information; Thrombosis

  MAUDE report 9914524 ↗
• InjuryDec 10, 2018Material Too Rigid or Stiff; Incomplete Coaptation; Material Too Rigid or Stiff; Incomplete Coaptation

  ON (B)(6) 2018 A PATIENT WAS TREATED FOR RECENT MITRAL INSUFFICIENCY WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO LAD AND NEW ONSET SEVERE MITRAL REGURGITATION AND PARTIAL LA SEPTUM (COR-TRIATRIATUM). THE PATIENT UNDERWENT A CABG TO LAD, EXCISION OF THE PARTIAL SEPTUM IN THE LEFT ATRIUM AND MITRAL VALVE REPLACEMENT. THE SITE USED A CARBOMEDICS OPTIFORM F7-027, SN: (B)(4), MECHANICAL VALVE SEATED IN THE SUPRA ANNULAR POSITION. THE LEAFLETS WERE CHECK AND MOVEMENT WAS CONFIRMED. AFTER COMING OFF CPB PRIOR TO CLOSURE AN OCCASIONAL ASYNCHRONOUS MOVEMENT IN ONE OF THE LEAFLETS WAS DETECTED VIA TRANS-OESOPHAGEAL ECHO (TOE). THE PATIENT WAS PLACED BACK ON CPB AND THE VALVE WAS INSPECTED. NO ISSUES WERE FOUND AND NO MECHANICAL HINDERANCE WAS VISIBLE FROM ANY SURROUNDING TISSUE. THE PATIENT WAS TAKEN OFF CPB AND TOE WAS PERFORMED. THE SAME ISSUE WAS OBSERVED. THE SITE THEN REMOVED THE CARBOMEDICS DEVICE AND IMPLANTED A TTK CHITRA 27 VALVE. THE SITE REPORTED PROFUSE BLEEDING DUE TO THE LONG PROCEDURE TIMES AND TRANSFUSION REQUIRED.

  Patient problems: Mitral Insufficiency

  MAUDE report 8149282 ↗
• InjuryMay 7, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  A MITRAL VALVE REPLACEMENT WAS PERFORMED, AND A CARBOMEDICS OPTIFORM VALVE WAS IMPLANTED. AFTER IMPLANTING THE VALVE, THE LEAFLET MOBILITY WAS AASSESSED WITH A TESTED AND APPEARED NORMAL; HOWEVER, DURING WEANING FROM BYPASS, THE VALVE LEAFLETS WERE NOT MOVING, AS OBSERVED BY ECHOCARDIOGRAPHY. AFTER CONVERTING TO BYPASS ONCE MORE, THE VALVE WAS OBSERVED TO BE IN THE CLOSED POSITION. WHEN THE LEAFLET WAS ROTATED, IT STARTED OPENING. THE CHEST WAS THEN CLOSED AND THE OPERATION WAS FINISHED. IT WAS REPORTED THAT THERE WAS NO PROTRUDING TISSUE OR CHORDA TENDINEA AROUND IMPLANTED AREA, WHICH COULD INHIBIT NORMAL VALVE MOBILITY. IT WAS FURTHER STATED THAT THE SIZE 29MM VALVE WAS APPROPRIATE FOR THE PATIENT, AND THE VALVE WAS NOT OVER-SIZED. THE PATIENT OUTCOME WAS GOOD, HOWEVER THE SURGERY WAS PROLONGED AS A RESULT OF THE EVENT. THE EXTENT OF THE DELAY WAS NOT REPORTED.

  Patient problems: No Information

  MAUDE report 7492778 ↗
• InjuryAug 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2017 THE MANUFACTURER RECEIVED NOTIFICATION THROUGH PATIENT TRACKING OF THE FOLLOWING EVENT: ON (B)(6) 2017 AN OPTIFORM PROSTHETIC MITRAL HEART VALVE F7-027 WAS EXPLANTED AND A NEW F7-027 WAS THEN IMPLANTED.

  Patient problems: No Information

  MAUDE report 6786851 ↗