Masters Series™ 29MJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05415067045058), received between May 13, 2024 and Jul 13, 2026 — classified as 2 deaths, 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 27MM EPIC PLUS MITRAL VALVE WAS IMPLANTED IN THE PATIENT. ON (B)(6) 2026, A DIZZINESS WAS OBSERVED IN THE PATIENT PRIOR TO RESECTION. A MASS-LIKE ATTACHMENT WAS FOUND ON THE VALVE. THE VALVE GOT EXPLANTED AND A NEW 27MM EPIC PLUS MITRAL VALVE WAS IMPLANTED. THE EXPLANTED VALVE HAD A SLIGHT PANNUS-LIKE STRUCTURE WAS ATTACHED TO THE COMMISSURAL AREA. THERE WAS NO TEAR WAS OBSERVED IN THE LEAFLETS AND SUTURE CUFF. THE PATIENT WAS REPORTED STABLE AND HOSPITALIZED.

  Patient problems: Insufficient Information; Movement Disorder; Thrombosis/Thrombus

  MAUDE report 25802999 ↗
• DeathJun 5, 2026Fracture; Improper or Incorrect Procedure or Method; Incomplete Coaptation; Physical Resistance/Sticking

  IT WAS REPORTED ON (B)(6) 2026 A 29MM MASTERS MITRAL VALVE WAS SELECTED FOR IMPLANT FOR MITRAL VALVE REPLACEMENT. THE PATIENT'S POSTERIOR WALL WAS NOTED TO BE SEVERELY CALCIFIED, WHICH FIRST REQUIRED A CALCIFICATION RESECTION. THE VALVE WAS IMPLANTED. ON POSTOPERATIVE DAY 2, LEAFLET MOTION RESTRICTION WAS NOTED DURING ECHOCARDIOGRAPHY, AND THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE. THE POSTERIOR WALL WAS DECALCIFIED SEVERAL TIMES. THE DEVICE REMAINED STABLE. A SECOND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) LEAFLET MOTION RESTRICTION WAS OBSERVED AGAIN, AND THE DEVICE WAS NOT ROTATED. THE DECISION WAS MADE TO EXPLANT THE DEVICE. WHILST REMOVING THE DEVICE, THE DEVICE WAS DAMAGED. A NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT WAS STABLE WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) IN THE INTENSIVE CARE UNIT (ICU). FIVE DAYS LATER THE PATIENT PASSED AWAY. THE PHYSICIAN BELIEVED THE ISSUE WAS RELATED WITH THE HEAVY CALCIFICATION ON THE MITRAL VALVE AND POSTERIOR WALL.

  Patient problems: Insufficient Information; Shock

  MAUDE report 25415266 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT CARDIAC SURGERY ON (B)(6) 2025, INCLUDING SEPTAL MYOMECTOMY AND AN ATTEMPTED MITRAL VALVE REPAIR WITH AN ANNULOPLASTY RING. DUE TO INTRAOPERATIVE FAILURE OF THE REPAIR, THE PROCEDURE WAS CONVERTED TO MITRAL VALVE REPLACEMENT WITH IMPLANTATION OF A MASTER SERIES MECHANICAL HEART VALVE (ABBOTT / (B)(6) . THE SURGICAL COURSE WAS CHARACTERIZED BY PROLONGED AND CUMULATIVE AORTIC CROSS-CLAMP TIME OF APPROXIMATELY 206 MINUTES, RESULTING FROM AN EXTENDED INITIAL REPAIR ATTEMPT FOLLOWED BY RE-CLAMPING FOR VALVE REPLACEMENT. POSTOPERATIVELY, THE PATIENT DEVELOPED SEVERE HEMODYNAMIC INSTABILITY AND CARDIOGENIC SHOCK, WITH BIOLOGICAL MARKERS DEMONSTRATING EXTENSIVE MYOCARDIAL INJURY (MARKEDLY ELEVATED TROPONIN, CK/CK-MB, AND BNP VALUES), CONSISTENT WITH A MAJOR PERIOPERATIVE MYOCARDIAL INFARCTION. THE CLINICAL EVOLUTION WAS FURTHER COMPLICATED BY ACUTE HEART FAILURE REQUIRING PROLONGED HIGH-DOSE INOTROPIC AND VASOPRESSOR SUPPORT, RESPIRATORY FAILURE, SEPTIC SHOCK, AND MULTIORGAN DYSFUNCTION. THE PATIENT REQUIRED MULTIPLE SURGICAL REINTERVENTIONS, RENAL REPLACEMENT THERAPY, PROLONGED MECHANICAL VENTILATION WITH TRACHEOSTOMY, GASTROSTOMY, AND EXTENDED INTENSIVE CARE AND HOS

  Patient problems: Heart Failure/Congestive Heart Failure; Ischemia; Low Blood Pressure/ Hypotension; Myocardial Infarction; Obstruction/Occlusion; Renal Failure; Respiratory Insufficiency; Sepsis; Shock; Unspecified Infection

  MAUDE report 25237019 ↗
• MalfunctionApr 10, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN TO ADDRESS MITRAL VALVULOPLASTY. DURING PROCEDURE, ONCE THE PROSTHETIC DEVICE HAD BEEN IMPLANTED, AN ATTEMPT WAS MADE TO ROTATE THE VALVE TO FACILITATE THE OPENING OF BOTH LEAFLETS; HOWEVER, ONE OF THE LEAFLETS FRACTURED. CONSEQUENTLY, THE DECISION WAS MADE TO EXPLANT THE DEVICE AND IMPLANT A NEW 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839604 ↗
• InjuryJan 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR A MITRAL VALVE REPLACEMENT BY VIDEO-ASSISTED THORACOTOMY. DURING PROCEDURE, AT THE END OF THE FIXATION OF THE PROSTHESIS, THEY NOTICED A DISAPPEARANCE OF A TAB, WHICH FORCED US TO REMOVE THE IMPLANTED PROSTHESIS AND PUT ANOTHER PROSTHESIS BACK IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040396 ↗
• InjuryDec 24, 2025Fracture; Fracture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888091 ↗
• InjuryAug 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE PHYSICIAN ALREADY MEASURED THE DEFECT AND WERE ABOUT TO BEGIN SUTURING IT AND TRIED TO INSERT THE VALVE. AT THAT MOMENT, ONE OF THE VALVE LEAFLETS DETACHED, SO IT WAS DECIDED TO REMOVE THE ENTIRE VALVE. THE DETACHED LEAFLET WAS RECOVERED FROM THE PATIENT IN ONE PIECE. THE DEFECTIVE VALVE WAS REMOVED AND REPLACED WITH A NEW ONE. THE PATIENT SPENT MORE TIME ON CARDIOPULMONARY BYPASS AND MORE TIME IN INTENSIVE CARE. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FOR VENTRICULAR FAILURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Heart Failure/Congestive Heart Failure; Pneumonia

  MAUDE report 22911844 ↗
• MalfunctionAug 8, 2025Fracture; Incomplete Coaptation; Fracture; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 29 MM MASTERS VALVE WAS SELECTED FOR IMPLANT. AFTER THE VALVE WAS IMPLANTED, THE VALVE LEAFLETS WERE NOTED TO BE MISALIGNED WHEN THEY OPENED AND CLOSED. WHILE TESTING THE OPENING AND CLOSING USING THE VALVE TESTING DEVICE AND ATTEMPTING REPOSITIONING OF THE VALVE, ONE OF THE LEAFLETS FRACTURED. THE PIECE WAS RETRIEVED FROM THE PATIENT AND IT IS UNKNOWN IF A REPLACEMENT DEVICE WAS USED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750283 ↗
• DeathMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ON (B)(6) 2021, A 29MM MASTERS MITRAL MECHANICAL HEART VALVE WAS IMPLANTED. ON (B)(6) 2024, SUDDEN HEART FAILURE OCCURRED AND THE PATIENT WAS HOSPITALIZED. ULTRASOUND IMAGING SHOWED A DISLODGED VALVE LEAFLET. THE VALVE WAS SURGICALLY REMOVED AND REPLACED, HOWEVER THE DISLODGED LEAFLET WAS NOT RECOVERED AND ITS EMBOLIZED TO COMMON ILIAC ARTERY. THERE WAS A PARTIAL BLOCKAGE OF BLOOD FLOW. THE PATIENT WAS REPORTED TO BE UNSTABLE. THE PATIENT REMAINED IN THE INTENSIVE CARE UNIT (ICU) ON A VENTILATOR. IN THE OPINION OF THE PHYSICIAN, THE EMBOLIZED LEAFLET LED TO ACUTE HEART FAILURE AND EVENTUALLY INFECTIONS OF ORGANS THROUGHOUT THE BODY UNTIL THE PATIENT PASSED AWAY ON (B)(6) 2024 FROM A SEVERE LUNG INFECTION.

  Patient problems: Embolism/Embolus; Foreign Body In Patient; Heart Failure/Congestive Heart Failure; Obstruction/Occlusion; Respiratory Tract Infection; Unspecified Infection

  MAUDE report 19297279 ↗