Simulus™ 800SR32Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00643169182271), received between Mar 24, 2017 and May 28, 2026 — classified as 1 death, 26 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 5 YEARS POST IMPLANT OF THIS 32MM ANNULOPLASTY RING, IT WAS REPORTED THAT A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED NOTED MODERATE TRICUSPID REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 25313573 ↗
• InjuryMar 26, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT ON JANUARY 28, 2026, THE 32MM MITRAL ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC MITRAL VALVE PROSTHESIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21697301 ↗
• InjurySep 4, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 3 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT AN ECHOCARDIOGRAM (ECHO) DISCOVERED MODERATE TO SEVERE MITRAL REGRUGITATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD SYMPTOMS OF STA BLE DYSPNEA. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20133151 ↗
• InjuryJul 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK WAS NOTED. SUBSEQUENTLY, 15 DAYS LATER, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK. THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICES AND IMPLANT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 19794256 ↗
• InjuryMar 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, THE PATIENT DEVELOPED A COMPLETE HEART BLOCK. TEMPORARY PACING WAS ADMINISTERED UNTIL 4 DAYS POST IMPLANT OF THE ANNULOPLASTY RING, AND THE COMPLETE HEART BLOCK RESOLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 18896327 ↗
• InjuryMar 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, THE PATIENT DEVELOPED POST OPERATIVE ATRIAL FIBRILLATION. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH POTASSIUM INFUSION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 18887823 ↗
• InjuryMar 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST SURGERY, BUT THE SAME DAY AS IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE PATIENT EXPERIENCED BRADYCARDIA. THIS WAS TREATED WITH TEMPORARY PACING. NO ADVERSE PATIENT EFFECTS OR NEED FOR PERMANENT PACING WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 18886565 ↗
• InjuryMar 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 WEEKS AND 6 DAYS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A DIFFERENT MANUFACTURERS PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS LEFT VENTRICULAR PSEUDOANEURYSM. A 32MM TRICUSPID ANNULOPLASTY RING WAS ALSO IMPLANTED CONCOMITANTLY DURING THE INITIAL IMPLANT PROCEDURE. IT WAS ALSO REPORTED THAT AN ECHOCARDIOGRAM (ECHO) DISCOVERED PERICARDIAL EFFUSION. THE PATIENTS HOSPITAL ADMISSION WAS PROLONGED AND A BLOOD TRANSFUSION WAS ADMINISTERED. IT WAS ALSO REPORTED THAT 2 DAYS PRIOR TO THE REPLACEMENT, THE ATRIOVENTRICULAR GROOVE WAS RUPTURED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pericardial Effusion; Pseudoaneurysm

  MAUDE report 18871303 ↗
• InjuryFeb 29, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, MAJOR BLEEDING WAS REPORTED. THE PATIENT WAS TREATED WITH A BLOOD TRANSFUSION. IT WAS STATED THAT THERE WAS A BLOOD LOSS OF MORE THAN 1 LITRE THROUGH DRAINAGE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18808919 ↗
• DeathAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 32MM ANNULOPLASTY RING, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE ANNULOPLASTY RING OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 17650888 ↗
• InjuryAug 17, 2023Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 4 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT A TRANSTHORACIC ECHOCARDIOGRAM (TTE) DISCOVERED RECURRENT HIGHERGRADE MITRAL VALVE REGURGITATION. IT WAS ALSO REPORTED THAT THE PATIENT HAS NO CARDIAC SYMPTOMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17565428 ↗
• InjuryJun 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REPAIR WASN¿T WHAT PHYSICIAN WANTED SO IT WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17152323 ↗
• InjuryDec 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 3 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16035616 ↗
• InjuryOct 28, 2022Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 2 MONTHS POST IMPLANT OF THIS 32 MM MITRAL ANNULOPLASTY RING, ECHOCARDIOGRAM (ECHO) PERFORMED NOTED MODERATE MITRAL INSUFFICIENCY. SUBSEQUENTLY ONE MONTH LATER, THE 32 MM MITRAL ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15690828 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MODERATE TO SEVERE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15403476 ↗
• InjuryJun 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC MECHANICAL VALVE . THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14674511 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IN AN UNKNOWN DURATION POST IMPLANT OF THIS 32MM ANNULOPLASTY RING, THE PATIENT WAS HOSPITALIZED FOR MULTIPLE CEREBRAL CONVULSION. IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED NOTED EMBOLIC CEREBRAL INFARCTION ON BOTH SIDES OF THE ARTERIA CEREBRI MEDIA. IT WAS ALSO REPORTED THAT A TRACHEOTOMY WAS PERFORMED AND MEDICATIONS WERE GIVEN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 14060958 ↗
• InjuryJun 9, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN ANNULOPLASTY PRODUCT OF A DIFFERENT MODEL DUE TO MILD REGURGITATION CAUSED BY A SIZING MISMATCH. IT WAS REPORTED THE PATIENT HAD ANATOMICAL FEATURES THAT CAUSED DIFFICULTIES IN SIZING THE VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 11968715 ↗
• InjuryApr 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 10 MONTHS POST IMPLANT OF THIS 32 MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 34 MM ANNULOPLASTY RING OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11663613 ↗
• InjurySep 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32 MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33 MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10606720 ↗
• InjuryMay 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 10 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM NON MEDTRONIC ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 10101496 ↗
• InjuryFeb 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9665653 ↗
• InjuryAug 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOUR DAYS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING WITH REPLACEMENT OF THE NATIVE MITRAL CHORDAE TENDONAE, THE RING WAS EXPLANTED AND REPLACED WITH A MITRAL ANNULOPLASTY BAND OF UNKNOWN SIZE. THE NEOCHORDS WERE ALSO REPLACED. THE REASON FOR REPLACEMENT WAS SYSTOLIC ANTERIOR MOTION OF THE ANTERIOR LEAFLET OF THE MITRAL VALVE, WHICH RESULTED IN LEFT VENTRICULAR OUTFLOW TRACT (LVOT) OBSTRUCTION AND MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 7828415 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM ANNULOPLASTY RING IN THE MITRAL POSITION, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR EXPLANT WAS DUE TO RESIDUAL REGURGITATION. THE PHYSICIAN INDICATED THE RING FUNCTIONED AS EXPECTED, HOWEVER, IT DID NOT PROVIDE SATISFACTORY RESOLUTION OF THE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7517141 ↗
• InjuryApr 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 MONTH POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7469493 ↗