Simulus™ 800SR34Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00643169182264), received between Mar 14, 2017 and Oct 18, 2024 — classified as 34 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 3 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 34MM ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20483227 ↗
• MalfunctionJul 24, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 6 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DISCOVERED MODERATE MITRAL STENOSIS. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 19820204 ↗
• InjuryMay 9, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE SITE ASSESSED THAT THE EVENT IS NOT RELATED TO THE IMPLANT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19276941 ↗
• InjuryNov 13, 2023Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 8 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, MODERATE TO SEVERE MITRAL REGURGITATION (MR) WAS OBSERVED ON A ECHOCARDIOGRAM. IT WAS STATED THAT THE DEVICE WAS OBSERVED TO BE IN A STABLE AND CORRECT POSITION. IT WAS NOTED THAT THE PATIENT HAS NO CARDIAC SYMPTOMS AND IS FEELING WELL. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18117969 ↗
• InjuryMay 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 MONTH POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 36MM RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16972498 ↗
• InjuryMar 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT 2 YEARS AND 6 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16654077 ↗
• InjuryMar 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 12 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING AND 32MM TRICUSPID ANNULOPLASTY RING, THE PATIENT WAS ADMITTED DUE TO SUSPICION OF CARDIAC DECOMPENSATION. SYMPTOMS INCLUDED EDEMA, PRESYNCOPE, DIZZINESS AND SCLERAL JAUNDICE. IT WAS REPORTED THAT MODERATE TO SEVERE MITRAL REGURGITATION WAS OBSERVED UPON PERFORMING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A DIAGNOSTIC BLOOD TEST WAS PERFORMED AND DISCOVERED A HEMOGLOBIN OF 6.9 G/DL OR ANEMIA. A BLOOD TRANSFUSION WAS GIVEN. ONE DAY LATER, AN ECHOCARDIOGRAM (ECHO) AND TEE DISCOVERED MILD TO MODERATE TRICUSPID REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Anemia; Dizziness; Jaundice; Mitral Valve Insufficiency/ Regurgitation; Presyncope; Swelling/ Edema

  MAUDE report 16568232 ↗
• InjuryMar 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 11 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16521269 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 7 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT AN ECHOCARDIOGRAM (ECHO) PERFORMED NOTED MODERATE TO SEVERE MITRAL VALVE REGURGITATION. IT WAS STATED THAT THE PATIENT IS DISPLAYING THE SAME SYMPTOMS AS SEEN PRIOR TO THE MITRAL VALVE REPAIR. IT WAS ALSO REPORTED THAT THE PATIENT HAS A SCHEDULED FUTURE DIAGNOSTIC ASSESSMENT FOR A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND 4D-COMPUTED TOMOGRAPHY SCAN (4D-CT) TO DETERMINE IF A REINTERVENTION IS NEEDED. IT WAS REPORTED THAT 1 MONTH LATER, A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED WHICH NOTED SEVERE MITRAL VALVE REGURGITATION. SUBSEQUENTLY 2 MONTHS LATER, A CT SCAN DISCOVERED PRONOUNCED CALCIFICATION OF THE PATIENT'S MITRAL VALVE ANNULUS AND THE PATIENT'S NATIVE MITRAL VALVE LEAFLETS APPEARED THICKENED. IT WAS ALSO REPORTED THAT 3 DAYS LATER, THE ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC PRODUCT. IT WAS REPORTED THAT THE EVENT WAS NOT RELATED TO THE 34MM MITRAL ANNULOPLASTY RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16461313 ↗
• InjuryFeb 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY THIS ANNULOPLASTY BAND WAS IMPLANTED, BUT AFTER THE CONCLUSION OF THE SURGERY, THE PATIENT EXPERIENCED A SINUS ARREST. THIS WAS TREATED WITH TEMPORARY PACING AND RESOLVED 5 DAYS LATER. ADDITIONALLY, 2 DAYS POST SURGERY, THE PATIENT EXPERIENCED ATRIAL FIBRILLATION (AFIB). THIS WAS TREATED WITH ANTIARRHYTHMICS MEDICATION AND RESOLVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Non specific EKG/ECG Changes

  MAUDE report 16397123 ↗
• InjuryDec 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 7 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16016562 ↗
• InjuryApr 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 32MM MITRAL ANNULOPLASTY RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. IT WAS ALSO REPORTED THAT DURING THE PROCEDURE, BLEEDING OCCURRED WHICH RESULTED IN REDUCED HEMOGLOBIN LEVELS AND THE PATIENT WAS TRANSFUSED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13996920 ↗
• InjuryFeb 16, 2022Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS 29 DAYS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE DUE TO DEHISCENCE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13543870 ↗
• InjuryDec 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 12 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12908237 ↗
• InjuryNov 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY DEVICE WAS IMPLANTED TO REPAIR THE PATIENT'S NATIVE MITRAL VALVE. IT WAS REPORTED THAT THE PATIENT "DID NOT WAKE UP PROPERLY AFTER THE SURGERY" AND THAT AN ACUTE STROKE COULD NOT BE RULED OUT. IT WAS REPORTED THAT THE PATIENT HAD "CRITICAL ILLNESS" AND POLYNEUROPATHY. LATER IN THE DAY, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. A RE-DO THORACOTOMY WAS PERFORMED TO TREAT THE EFFUSION. FOLLOWING THE RE-DO THORACOTOMY, ECHOCARDIOGRAM REVEALED A MILD PERICARDIAL EFFUSION. TWO DAYS POST SURGERY, NEUROLOGICAL EVALUATION REVEALED NO SIGNS OF ACUTE STROKE AND ECHOCARDIOGRAM ON THE SAME DATE SHOWED NO PERICARDIAL EFFUSION. IT WAS REPORTED THAT THE SURGEON BELIEVED THE PERICARDIAL EFFUSION AND NEUROLOGICAL ISSUES BOTH HAD A "POSSIBLE" RELATION TO THE ANNULOPLASTY DEVICE AND A "PROBABLE" RELATIONSHIP TO THE ORIGINAL PROCEDURE. TWENTY-THREE (23) DAYS FOLLOWING THE MITRAL VALVE REPAIR SURGERY, THE PATIENT RECEIVED A TRACHEOSTOMY FOR LONG-TERM VENTILATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pericardial Effusion; Respiratory Failure; Unspecified Nervous System Problem

  MAUDE report 12901943 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 34 MM MITRAL ANNULOPLASTY RING, ATRIAL FIBRILLATION (AFIB) WAS OBSERVED. IT WAS REPORTED THE PATIENT DEVELOPED TACHYCARDIA-BRADYCARDIA SYNDROME WITH THE HEART RATE DROPPING TO 30 BPM. A PERMANENT PACEMAKER WAS IMPLANTED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Bradycardia; Tachycardia

  MAUDE report 12803505 ↗
• InjuryOct 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS DUE TO MODERATE MITRAL INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Pulmonary Edema

  MAUDE report 12638657 ↗
• MalfunctionJun 24, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  MEDTRONIC RECEIVED INFORMATION THAT THIS 34MM ANNULOPLASTY RING WAS IMPLANTED 19 DAYS POST EXPIRATION DATE. IT WAS REPORTED THAT "SURGEON KNOWINGLY IMPLANTED EXPIRED PRODUCT". NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12062494 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 25MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS CONTINUED SEVERE REGURGITATION POST IMPLANT. IT WAS REPORTED THERE WAS NO ISSUE WITH THE DEVICE, RATHER THE PATIENTS PATHOLOGY CONTRIBUTED TO THE NEED FOR AORTIC VALVE REPLACEMENT (AVR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 11195652 ↗
• InjuryNov 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 1 YEAR AND 4 MONTHS POST IMPLANT OF THIS 34 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 10796678 ↗
• InjuryAug 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10411035 ↗
• InjuryJul 24, 2020Incomplete Coaptation; Insufficient Device Problem Information; Incomplete Coaptation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10320442 ↗
• InjuryJul 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 7 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, IT 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 8807361 ↗
• InjuryJun 3, 2019Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8665075 ↗
• InjuryApr 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 34MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8560397 ↗