SJM™ Masters Series 29MJ-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05414734006552), received between Sep 7, 2018 and Dec 29, 2023 — classified as 3 deaths, 10 injuries, 4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON 05 DECEMBER 2023, A 29MM MITRAL MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANT. A RESISTANCE WAS MET WHEN ROTATING THE VALVE WITH THE VALVE ROTATOR. THE VALVE WAS PLACED ON THE MITRAL VALVE. DURING SUTURING OF THE VALVE, IT WAS OBSERVED THAT THE VALVE LEAFLET DISLODGED AS ONE PIECE. THE VALVE WAS OPENED AND REMOVED. THE INTACT LEAFLET WAS RECOVERED FROM THE PATIENT. A 29MM NON-ABBOTT REPLACEMENT VALVE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416462 ↗
• InjuryMay 18, 2023Incomplete Coaptation; Patient Device Interaction Problem; Incomplete Coaptation; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM MITRAL MASTERS SERIES STD VALVE WAS SELECTED FOR IMPLANT IN THE PATIENT. AT THE TIME OF DEVICE PREPARATION, THE LEAFLETS WERE MOVING NORMALLY. AFTER IMPLANTATION OF THE VALVE, THE PHYSICIAN CLOSED THE INCISION OF HEART. THE PHYSICIAN FOUND THAT ONE LEAFLET OF VALVE COULDN'T MOVE DURING THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THEN THE PHYSICIAN STOPPED THE BLOOD CIRCULATION AND OPENED THE HEART INCISION AGAIN. HE FOUND THAT THERE WAS SOME THROMBUS IN THE PIVOT OF VALVE WHICH AFFECTED THE FUNCTION OF ONE LEAFLET. SO THE PHYSICIAN EXPLANTED THE VALVE, THEN REPLACED WITH A NON-ABBOTT DEVICE. THE PROCEDURE TIME WAS EXTENDED ABOUT 45 MINUTES. THE PATIENT WAS GIVEN HEPARIN WITH ACTIVATED CLOTTING TIME (ACT) OF >500 SECONDS. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND IS CURRENTLY SAFE AND STABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16954194 ↗
• MalfunctionMar 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANT. IT WAS OBSERVED THAT THE VALVE HAD A DEFECT AND ONE OF THE LEAFLETS HAD DISLODGED. A REPLACEMENT 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS THEN SUCCESSFULLY IMPLANTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576789 ↗
• MalfunctionMar 17, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, BUT PRIOR TO IMPLANT, THE PHYSICIAN FELT A SENSE OF INCONGRUITY, THEREFORE AVOIDED USING THE DEVICE. IT WAS OBSERVED OPENING AND CLOSING THE LEAFLET WAS NOT AS SMOOTH AS USUAL. DEVICE WAS REPLACE WITH A (EPIC 31MM) WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564463 ↗
• DeathJul 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT ON 29MM MITRAL MASTERS VALVE WAS SELECTED FOR IMPLANT ON (B)(6) 2022. DURING THE PROCEDURE A LEAFLET OF THE MASTERS VALVE BROKE. NO FURTHER INFORMATION WAS PROVIDED ABOUT THE PROCEDURE. THE PATIENT'S STATUS WAS NOTED AS DECEASED. THE DATE AND CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14997570 ↗
• InjuryJun 3, 2022Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT IMPLANT OF A 29MM MASTERS SERIES MITRAL VALVE. DURING THE PROCEDURE, WHILE THE VALVE RING WAS BEING SUTURED, ONE OF THE LEAFLETS FELL OFF WHEN THE VALVE WAS TESTED WITH A SILICONE LEAFLET TESTER. THE USER REMOVED THE VALVE FROM THE PATIENT AND EXCHANGED IT WITH A NEW 29MM MASTERS SERIES MITRAL VALVE. AFTER THE VALVE WAS REMOVED, IT WAS CONFIRMED THAT THE LEAFLETS AND RINGS WERE INTACT. ALL LEAFLETS WERE RETRIEVED FROM THE PATIENT. THE EVENT DID CAUSE A PROLONGED PROCEDURE AS THE PATIENT REQUIRED AN ADDITIONAL HOUR ON CARDIOPULMONARY BYPASS AND REQUIRED ADMISSION TO THE INTENSIVE CARE UNIT. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598862 ↗
• InjuryApr 27, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 29MM MASTERS SERIES MITRAL VALVE WAS CHOSEN FOR PROCEDURE. DURING THE PROCEDURE, AFTER THE VALVE WAS PLACED, IMAGING WAS PERFORMED WHICH REVEALED A LEAK. THE AO WAS UN-CLAMPED AND EXTRACORPOREAL CIRCULATION (ECC) WAS STARTED. THE LEAK (MINIMAL) WAS DISCOVERED ON THE POST IMPLANT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND THE PATIENT WAS RE-OPENED. BLOOD WAS OBSERVED LEAKING BETWEEN LEAFLETS WHEN THE LEAFLETS WERE COMPLETELY CLOSED. AFTER RE-OPENING THE RIGHT SIDE OF THE LEFT ATRIA, THE MITRAL REGURGITATION WAS CONFIRMED HOWEVER THE PHYSICIAN DID NOT FEEL IT WAS SEVERE AND DID NOT REQUIRE REPLACEMENT. THE DECISION WAS MADE TO KEEP THE DEVICE IN PLACE. THE PATIENT DID REMAIN STABLE THROUGHOUT THE PROCEDURE DESPITE THE FACT THE PROCEDURE WAS PROLONGED BY A REPORTED 30 TO 40 MINUTES. THE DEVICE REMAINS IMPLANTED. A TOOTH INFECTION HAD BEEN REPORTED POST-OPERATIVELY.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 14216897 ↗
• InjuryOct 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2021, A 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. DURING PROCEDURE, "AFTER TAKING SUTURE BITES WHILE ROTATION THE VALVE, THE LEAFLET FROM THE HINGES GOT FRACTURED," FURTHER DESCRIBED AS AFTER THE SUTURES WERE REMOVED FROM THE VALVE. ALL PIECES OF THE VALVE WERE CONFIRMED TO HAVE BEEN REMOVED FROM THE PATIENT. A NON-ABBOTT VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE USER ALLEGED A PROLONGED PROCEDURE TIME OF APPROXIMATELY 120 MINUTES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12660086 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) A 30MM SJM RIGID SADDLE RING WAS SELECTED FOR IMPLANT. AFTER PLACING THE RING A LEAK WAS NOTED BY PERFORMING A LEAK TEST. THE RING WAS REMOVED AND EXCHANGED WITH A 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE. AFTER PLACING THE MECHANICAL VALVE NO PARAVALVULAR LEAK OR REGURGITATION WAS NOTED AND PROCEDURE WAS COMPLETED WITHOUT AND COMPLICATIONS. ON(B)(6) A CT SCAN WAS PERFORMED BUT DIDN'T SHOW ANY ABNORMALITIES. ON (B)(6) 2021, THE PATIENT WAS GIVEN LEVETIRACETAM. ON (B)(6) 2021, RIGHT SIDED STROKE WAS NOTED WITH ACUTE SYMPTOMATIC EPILEPSY AND A MRI WAS PERFORMED. THE SAME DAY THE PATIENT WAS GIVEN ACENOCOUMAROL. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND SINCE HAS BEEN DISCHARGED. ((B)(4)).

  Patient problems: Epilepsy; Stroke/CVA

  MAUDE report 12455702 ↗
• DeathJul 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 29 MM ST. JUDE MEDICAL (SJM) MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR PROCEDURE OF A MITRAL VALVE REPLACEMENT. AFTER THE DEVICE WAS IMPLANTED INTO THE MITRAL VALVE, ONE OF THE VALVE LEAFLETS DISLODGED AS ONE PIECE. THIS OCCURRED WHEN THE VALVE RETENTION SUTURES WERE BEING CUT BUT BEFORE THE VALVE COULD BE ROTATED. THE DISLODGED LEAFLET WAS RECOVERED FROM THE PATIENT, AND THE DEVICE WAS EXPLANTED. A 31 MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN AS A DEVICE REPLACEMENT AND WAS SUCCESSFULLY IMPLANTED. ACCORDING TO THE PHYSICIAN, THE PROLONGED CARDIOPULMONARY BYPASS TIME WAS PROLONGED BY APPROXIMATELY 60 MINUTES DUE TO THIS EVENT. AFTER THE SURGERY, THE PATIENT DEVELOPED CARDIOGENIC SHOCK AND HEART FAILURE. THE PATIENT WAS PLACED ON INTRA-AORTIC BALLOON PUMP THERAPY AND ADDITIONAL INTRAVENOUS (IV) MEDICATIONS TO TREAT THE POST-PROCEDURE SYMPTOMS. THE PATIENT WAS REPORTED TO BE STABLE POST-PROCEDURE. LATER, IT WAS REPORTED THAT THE PATIENT DIED OF CARDIORESPIRATORY ARREST ON (B)(6) 2021 WHILE BEING TRANSFERRED TO ANOTHER HOSPITAL VIA AMBULANCE. THE CAUSE OF DEATH WAS THOUGHT TO BE RELATED TO INITIAL 29 MM MASTERS VALVE THAT

  Patient problems: Cardiogenic Shock; Heart Failure/Congestive Heart Failure

  MAUDE report 12240084 ↗
• Apr 5, 2021Device Markings/Labelling Problem

  EXPIRED MECHANICAL HEART VALVE WAS IMPLANTED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11618751 ↗
• MalfunctionMar 30, 2020Material Separation; Material Separation

  ON (B)(6) 2019, A 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT IN THE PATIENT. DURING THE PROCEDURE, DISLODGEMENT OF THE LEAFLET WAS DIAGNOSED INTRA-OPERATIVELY BY TEE AFTER THE AORTIC CLAMP WAS OFF. THE VALVE WAS REPLACED WITH ANOTHER VALVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9899454 ↗
• InjuryNov 25, 2019Material Separation; Material Separation

  ON (B)(6) 2019, A 29 MM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT. WHILE ROTATING THE VALVE, A LEAFLET DISLODGED. THE LEAFLET AND VALVE WERE REMOVED AND THE DEVICE WAS EXCHANGED WITH ANOTHER MASTERS VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, BUT IT TOOK AN HOUR TO ARRANGE THE REPLACEMENT VALVE RESULTING IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9368733 ↗
• InjuryNov 20, 2019Perivalvular Leak; Perivalvular Leak

  RELATED MANUFACTURER REPORT NUMBER: 2648612-2019-00100. ON (B)(6) 2015, THE PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT AND CONCOMITANT AORTIC VALVE REPLACEMENT FOR RHEUMATIC MITRAL VALVE AND TRICUSPID VALVE UNION DISEASE. DURING A FOLLOW-UP ON (B)(6) 2016, IT WAS IDENTIFIED THE PATIENT DIED OF CARDIAC ARREST. THE PATIENT HAD EXPERIENCED PARAVALVULAR LEAKAGE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 9347873 ↗
• InjuryJan 11, 2019Fracture; Fracture

  ON (B)(6) 2018, A 29MM MASTERS VALVE WAS SELECTED FOR IMPLANT IN THE MITRAL POSITION. WHILE ROTATING THE VALVE, THE LEAFLET FRACTURED AND BROKEN INTO PIECES. THE VALVE AND ALL FRACTURED PIECES WERE REMOVED FROM THE PATIENT AND A 29MM MEDTRONIC AP VALVE WAS IMPLANTED. THE PROCEDURE WAS SIGNIFICANTLY EXTENDED AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8239407 ↗
• InjuryNov 15, 2018Obstruction of Flow; Obstruction of Flow

  ON 12 SEPTEMBER 2018, A 29MM MASTERS HEART VALVE WAS SELECTED FOR IMPLANT IN THE MITRAL POSITION AFTER A 905 SIZER SET WAS USED TO MEASURE THE VALVE. AFTER IMPLANT, ONLY ONE LEAFLET WAS OBSERVED TO MOVE. PER REPORT, THE LEAFLET WAS NOT CAUGHT BY THE NATIVE TISSUE AND WAS NOT OPENING DUE TO THE HINGE. THE PROCEDURE WAS COMPLETED WITH A 29MM LEAFLET VALVE (SN: (B)(4)). THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE EXTENDED PROCEDURE (3 HOURS ADDITIONAL OR TIME, BUT NO ADDITIONAL CROSS CLAMP TIME NEEDED) AND IS REPORTED STABLE AFTER SURGERY. ECHO AND OP REPORTS WERE REQUESTED, BUT NOT MADE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073466 ↗
• InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH MITRAL REGURGITATION (MR). ON (B)(6) 2015, HYPERTENSION WAS DIAGNOSED. ON (B)(6) 2015, A MVR WAS PERFORMED AND THIS 29 MM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED. SIMULTANEOUSLY, THE ATRIAL SEPTAL DEFECT (ASD) WAS SURGICALLY CLOSED WITH AN AUTOLOGOUS PERICARDIAL PATCH. POSTOPERATIVELY, THE PATIENT WAS TREATED WITH ANTICOAGULANTS; HOWEVER, THE PATIENT DEVELOPED 4 EPISODES OF CARDIOGENIC CEREBRAL EMBOLISM ((B)(6) 2016, AND (B)(6) 2017). THE TARGET LEVEL OF INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME (PT-INR) WAS 3.0. THE PATIENT WAS TREATED AND HAD BEEN FOLLOWED UP IN A LOCAL CLINIC WITH A LATEST VALUE OF PT-INR AT 3.12. ON (B)(6) 2018, THE PATIENT WAS SLOW TO REACT, DID NOT SPEAK CLEARLY AND WAS UNSTEADY WHILE STANDING AND WALKING. UPON PRESENTING TO THE LOCAL CLINIC, THE PATIENT WAS IMMEDIATELY TRANSFERRED AND ADMITTED TO THE HOSPITAL DUE TO SUSPICION OF CEREBRAL INFARCTION. CARDIAC EXAM REVEALED SINUS AT 66 BPM. MRI REVEALED A NEW INFARCT IN THE LEFT FRONTAL LOBE. MRI WAS SUSPICION OF STENOSIS PERIPHERALLY FROM THE M3 SEGMENT OF LEFT MIDDLE CEREBRAL ARTERY BUT NO SIGNIFICANT STENOSIS LESION. PT-INR HAD BEEN MAINTAIN

  Patient problems: Stroke/CVA

  MAUDE report 7884948 ↗
• DeathSep 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, A 29MM MASTER MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT IN A (B)(6) YEAR OLD MALE PATIENT. THE PATIENT WAS REPORTED TO HAVE DIED DURING THE PROCEDURE ON THE OPERATING TABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Death

  MAUDE report 7857805 ↗