CARBOMEDICS STANDARD M7-027Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08022057012722), received between Aug 16, 2016 and Jul 17, 2025 — classified as 2 deaths, 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED THAT A DOUBLE VALVE PROCEDURE WITH STANDARD AORTIC AND STANDARD MITRAL WAS PERFORMED ON (B)(6) 2025. AS REPORTED, ALL LOOKED GOOD IN OR. ABOUT 10 DAYS POST-OP PATIENT HAD EFFUSION/HF AND ECHO SHOWED A JAMMED LEAFLET ON MITRAL VALVE. AS SUCH, PATIENT WAS TAKEN BACK TO OR AND SAW SOME MINIMAL PANNUS/TISSUE SURROUNDING THE OCCLUDED LEAFLET. THE PANNUS/TISSUE WAS CLEANED OUT AND USED A RUBBER POKER AND FREED THE LEAFLET. THERE WAS NO SUB-VALVULAR TISSUE. THE VALVE WAS ROTATED 30 DEGREES AND BOTH LEAFLETS FUNCTIONED WELL, AND ECHO WAS FINE IN CVICU. ABOUT 7 DAYS LATER PATIENT HAD EFFUSION/HF AND ECHO SHOWED ONE LEAFLET JAMMED IN OPEN POSITION AND ONE LEAFLET WITH LIMITED MOVEMENT. PATIENT WAS TAKEN BACK TO OR ON (B)(6) AND THE CARBOMEDICS MITRAL 27MM WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS MITRAL SIZE 25MM. REPORTEDLY, PROCEDURE WENT WELL WITH MITRAL VALVE FUNCTIONING PROPERLY, PATIENT IS IN ICU DOING WELL.

  Patient problems: Heart Failure/Congestive Heart Failure; Pericardial Effusion

  MAUDE report 22536500 ↗
• InjuryMay 25, 2021Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2021, A PATIENT RECEIVED A CARBOMEDICS STANDARD MITRAL VALVE M7-027. AFTER IMPLANTATION, VASCULAR ULTRASOUND (TEE) FOUND THAT ONE OF THE LEAFLETS WAS NOT FLEXIBLE MOVED ENOUGH, SITUATION WAS NOT IMPROVED AFTER ROTATED THE VALVE IN ONE DIRECTION. AS REPORTED, ONE LEAFLET WAS MOVING CORRECTLY, WHILE THE MOVEMENT OF THE SECOND LEAFLET WAS NOT VERY SMOOTH. IT WAS ATTEMPTED TO TURN THE LEAFLET HORIZONTALLY TO RIGHT AND LEFT TO ADJUST. AFTER THE CARDIAC REPULSE, THE ESOPHAGUS ULTRASOUND (TEE) WAS OBSERVED AND IT INDICATED THAT THE VALVE LEAFLET WAS INFLEXIBLE AND AFFECTED BLOOD FLOW. IT WAS REPORTED THAT THE VALVE WAS ALSO TESTED WITH THE DEDICATED TESTER AND THE RESULTS WERE AS DESCRIBED ABOVE. SO FINALLY THE VALVE WAS EXPLANTED INTRAOPERATIVELY AND IT WAS REPLACED WITH A M7-025. REGARDING THE CHANGE IN SIZE, THE SURGEON REPORTED THAT THE SIZING WAS WITH NO PROBLEM. THE PATIENT REMAINED STABLE DURING THE PROCEDURE WITH A GOOD OUTCOME AFTER SURGERY. WITH REGARDS TO THE SURGICAL APPROACH, IT WAS REPORTED THAT THE LEAFLETS, CHORDAE WERE RESECTED AND THAT THE PAPILLARY MUSCLES WERE KEPT.

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

  MAUDE report 11881917 ↗
• InjuryMay 25, 2021Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2021, A PATIENT RECEIVED A CARBOMEDICS STANDARD MITRAL VALVE M7-027. AFTER IMPLANTATION, VASCULAR ULTRASOUND (TEE) FOUND THAT ONE OF THE LEAFLETS WAS NOT FLEXIBLE MOVED ENOUGH, SITUATION WAS NOT IMPROVED AFTER ROTATED THE VALVE IN ONE DIRECTION. AS REPORTED, ONE LEAFLET WAS MOVING CORRECTLY, WHILE THE MOVEMENT OF THE SECOND LEAFLET WAS NOT VERY SMOOTH. IT WAS ATTEMPTED TO TURN THE LEAFLET HORIZONTALLY TO RIGHT AND LEFT TO ADJUST. AFTER THE CARDIAC REPULSE, THE ESOPHAGUS ULTRASOUND (TEE) WAS OBSERVED AND IT INDICATED THAT THE VALVE LEAFLET WAS INFLEXIBLE AND AFFECTED BLOOD FLOW. IT WAS REPORTED THAT THE VALVE WAS ALSO TESTED WITH THE DEDICATED TESTER AND THE RESULTS WERE AS DESCRIBED ABOVE. SO FINALLY THE VALVE WAS EXPLANTED INTRAOPERATIVELY AND IT WAS REPLACED WITH A M7-025. REGARDING THE CHANGE IN SIZE, THE SURGEON REPORTED THAT THE SIZING WAS WITH NO PROBLEM. THE PATIENT REMAINED STABLE DURING THE PROCEDURE WITH A GOOD OUTCOME AFTER SURGERY. WITH REGARDS TO THE SURGICAL APPROACH, IT WAS REPORTED THAT THE LEAFLETS, CHORDAE WERE RESECTED AND THAT THE PAPILLARY MUSCLES WERE KEPT.

  Patient problems: Insufficient Information

  MAUDE report 11881869 ↗
• MalfunctionMay 25, 2021Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2021, A CARBOMEDICS STANDARD MITRAL VALVE M7-027 WAS INTENDED TO BE IMPLANTED. DURING THE PROCEDURE, THE PHYSICIAN OPENED THE VALVE PRODUCT AND USED THE TESTER, THEN THEY FOUND ONE OF THE LEAFLETS CANNOT BE OPENED AFTER THE KNOT (I.E SUTURING). THE PATIENT IS REPORTEDLY NOT AFFECTED BY THE EVENT. PER ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT THE LEAFLET DYSFUNCTION WAS IDENTIFIED AFTER THE SUTURING WAS COMPLETED. THE SURGICAL APPROACH USED WAS SUTURE EVERTING, AND RESECTION OF THE NATIVE MITRAL VALVE (LEAFLETS, CHORDAE AND PAPILLARY MUSCLES). THE LEAFLETS WERE TESTED WITH THE DEDICATED TESTER. THE DEVICE WAS ULTIMATELY REPLACED WITH A CARBOMEDICS STANDARD MITRAL VALVE M7-25. IT WAS CLARIFIED ALSO THAT THE PATIENT REMAINED STABLE AND THE OUTCOME WAS GOOD, NO IMPACT ON PATIENT. FURTHERMORE, IT WAS REPORTED THAT THERE IS NO ABNORMAL FOUND AT THE ECHO FOR THE FIRST IMPLANTING CPHV VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881682 ↗
• InjuryMay 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020 A PATIENT WAS INTENDED TO RECEIVE A CARBOMEDICS STANDARD M7-027 MECHANICAL MITRAL HEART VALVE. THE MANUFACTURER WAS NOTIFIED THAT THE VALVE WAS REMOVED INTRA-OPERATIVELY. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 10084744 ↗
• InjuryMay 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020 A PATIENT WAS INTENDED TO RECEIVE A CARBOMEDICS STANDARD M7-027 MECHANICAL MITRAL HEART VALVE. THE MANUFACTURER WAS NOTIFIED THAT THE VALVE WAS REMOVED INTRA-OPERATIVELY. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 10084741 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2019, A PATIENT RECEIVED A CARBOMEDICS STANDARD MITRAL M7-027 TO REPLACE A BIOLOGICAL MITRAL PROSTHESIS IMPLANTED IN 2008. A GOOD POSTOPERATIVE COURSE IS INITIALLY REPORTED. HOWEVER, BETWEEN THE 7TH AND 9TH POD (POSTOPERATIVE DAY), THE PATIENT HAD AF WITH HIGH VR, WITH TACHYPNEA, MULTIPLE ORGAN DYSFUNCTION (RESPIRATORY, RENAL, LIVER FAILURE), WHICH RESULTED IN THE NEED FOR HIGH DOSES OF AMINES AND CONTINUOUS HEMODIALYSIS. REINTUBATION WAS NECESSARY, AND THE PATIENT DIED ON THE 10TH POD. THE CAUSES OF DEATH INDICATED IN THE DEATH CERTIFICATE ARE SEPTIC SHOCK, SEVERE SEPSIS, AND UNDEFINED-FOCUS INFECTION.

  Patient problems: Death; Sepsis; Septic Shock; Unspecified Infection

  MAUDE report 9324997 ↗
• DeathNov 14, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2019, A PATIENT RECEIVED A CARBOMEDICS STANDARD MITRAL M7-027 TO REPLACE A BIOLOGICAL MITRAL PROSTHESIS IMPLANTED IN 2008. A GOOD POSTOPERATIVE COURSE IS INITIALLY REPORTED. HOWEVER, BETWEEN THE 7TH AND 9TH POD (POSTOPERATIVE DAY), THE PATIENT HAD AF WITH HIGH VR, WITH TACHYPNEA, MULTIPLE ORGAN DYSFUNCTION (RESPIRATORY, RENAL, LIVER FAILURE), WHICH RESULTED IN THE NEED FOR HIGH DOSES OF AMINES AND CONTINUOUS HEMODIALYSIS. REINTUBATION WAS NECESSARY, AND THE PATIENT DIED ON THE 10TH POD. THE CAUSES OF DEATH INDICATED IN THE DEATH CERTIFICATE ARE SEPTIC SHOCK, SEVERE SEPSIS, AND UNDEFINED-FOCUS INFECTION.

  Patient problems: Death; Sepsis; Septic Shock; Unspecified Infection

  MAUDE report 9324928 ↗
• InjuryAug 7, 2019Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  ON (B)(6) 2019 A PATIENT RECEIVED A CARBOMEDICS STANDARD MITRAL VALVE M7-027 AS PART OF AN MVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY AND REPLACED WITH ANOTHER M7-027. NO FURTHER INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE ON (B)(6) 2019 IDENTIFYING THE FOLLOWING. THE DEVICE WAS NOT USED BECAUSE A LEAFLET WAS NOT FUNCTIONING NORMALLY. THE PATIENT HAD A NORMAL DISCHARGE AFTER USE OF ALTERNATIVE VALVE. THE DEVICE IS NOT AVAILABLE FOR RETURN OR ANALYSIS.

  Patient problems: No Information

  MAUDE report 8871072 ↗
• InjuryAug 7, 2019Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  ON (B)(6) 2019 A PATIENT RECEIVED A CARBOMEDICS STANDARD MITRAL VALVE M7-027 AS PART OF AN MVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY AND REPLACED WITH ANOTHER M7-027. NO FURTHER INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE ON SEP. 11, 2019 IDENTIFYING THE FOLLOWING. THE DEVICE WAS NOT USED BECAUSE A LEAFLET WAS NOT FUNCTIONING NORMALLY. THE PATIENT HAD A NORMAL DISCHARGE AFTER USE OF ALTERNATIVE VALVE. THE DEVICE IS NOT AVAILABLE FOR RETURN OR ANALYSIS.

  Patient problems: No Information

  MAUDE report 8870993 ↗
• InjuryMay 26, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2019, A MITRAL VALVE REPLACEMENT WITH A CARBOMEDICS STANDARD M7-027 WAS ATTEMPTED. HOWEVER, IT IS REPORTED THAT WHEN THE SURGEON IMPLANTED THE VALVE, SPECIFICALLY WHEN THE SUTURES HAVE ALREADY STARTED TO PASS THROUGH THE RING, HE DETECTED THAT THE SUTURE RING WAS NOT STITCHED CORRECTLY (THE PICTURE RECEIVED FROM THE FIELD SHOWED A HOLE IN THE SEWING CUFF). IT WAS REPORTED THAT SOME DIFFERENCE IN THE SEWING CUFF WAS NOTICED ALSO BEFORE THE IMPLANT, ALTHOUGH THESE DIFFERENCES WERE NOT FURTHER SPECIFIED, AND NO EVIDENCE WAS PROVIDED. THE DEVICE WAS CONSEQUENTLY EXPLANTED AND REPLACED WITH A CARBOMEDICS OF THE SAME SIZE. THE TOTAL CROSS-CLAMP TIME WAS 147 MIN AND THE TOTAL BYPASS TIME WAS 210 MIN. THE PATIENT REMAINED STABLE THROUGHOUT THE DELAY, WITH NO COMPLICATIONS. A GOOD OUTCOME IS ALSO REPORTED AFTER THE SURGERY. IT IS REPORTED THAT THE SUTURES/NEEDLE USED FOR THE PROCEDURE WERE THE BBRAUN PREMICRON 2/0.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8643118 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO A CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL M7-027 IMPLANTED ON (B)(6) 2016. IT WAS EXPLANTED AND REPLACED WITH ANOTHER SIMILAR DEVICE BUT BIGGER SIZE M7-029 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8329917 ↗
• InjuryOct 9, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A CARBOMEDICS STANDARD M7-027 VALVE WAS IMPLANTED AND EXPLANTED DUE TO MIS-SIZING. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: No Information

  MAUDE report 7949963 ↗
• InjuryMay 7, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A CARBOMEDICS OPTIFORM MITRAL HEART VALVE WAS IMPLANTED ON (B)(6) 2018. MIS-SIZING OF THE VALVE WAS IDENTIFIED POST-OPERATIVELY, AND IMMEDIATELY EXPLANTED AND REPLACED. IT WAS REPORTED THAT THE MIS-SIZING OCCURRED DUE TO THE SURGEON'S ERROR, AND THERE WERE NO CONCERNS ABOUT THE USABILITY OR FUNCTIONALITY OF THE DEVICE. THE PATIENT OUTCOME WAS GOOD.

  Patient problems: No Information

  MAUDE report 7491021 ↗
• DeathAug 16, 2016Mechanical Jam; Mechanical Jam

  DURING A PROCEDURE, ONE OF THE LEAFLETS BECAME STUCK AFTER THE HEART WAS CLOSED. ON (B)(6) 2016: A PROCEDURE WAS STARTED TO PERFORM MITRAL VALVE REPLACEMENT (MVR) AND CORONARY ARTERY BYPASS GRAFTING (CABG) AT TWO SITES. FOR THE MVR PROCEDURE, THE CARBOMEDICS M7-027 (SN: (B)(4) - OBJECT OF THIS INITIAL REPORT) WAS IMPLANTED INTO THE MITRAL ANNULUS. AFTER THE LEAFLETS WERE CONFIRMED TO BE FUNCTIONING NORMALLY USING A LEAFLET TESTER, THE HEART WAS CLOSED. WHILE THE HEART-LUNG MACHINE WAS STILL OPERATING, ONE OF THE LEAFLETS WAS FOUND TO BE STUCK. THE HEART WAS RE-OPENED AND THE VALVE WAS TESTED AGAIN USING A LEAFLET TESTER. THE RESULT WAS THAT THE LEAFLETS WERE FUNCTIONING NORMALLY. HOWEVER, AFTER THE HEART WAS CLOSED AGAIN, THE STUCK OF THE LEAFLET RECURRED. THE CARBOMEDICS M7-027 WAS REPLACED WITH THE CARBOMEDICS M7-025 (SN: (B)(4) - OBJECT OF A DIFFERENT INITIAL REPORT). JUST IN CASE, THIS M7-025 VALVE WAS ROTATED TO BE IN A DIFFERENT ORIENTATION AND IMPLANTED BY A DIFFERENT SUTURING TECHNIQUE FROM THE PREVIOUS ONE. AFTER THE LEAFLETS WERE CONFIRMED TO BE FUNCTIONING NORMALLY USING A LEAFLET TESTER, THE HEART WAS CLOSED. SIMILARLY TO THE PREVIOUS VALVE, ONE OF THE LEAFLETS WAS FOUN

  Patient problems: Death

  MAUDE report 5878876 ↗