Simulus™ 800SR40Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169182233), received between Apr 2, 2017 and Nov 27, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 5 YEARS AND 3 MONTHS POST IMPLANT OF THIS 40MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 3 3MM MITRAL ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23664017 ↗
• InjuryJun 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS SIMULUS SR HEART RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS AV BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22319490 ↗
• InjuryJun 16, 2025Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE MITRAL REGURGITATION AND MILD MITRAL STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 22210232 ↗
• InjuryNov 15, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 9 MONTHS POST IMPLANT OF THIS 40MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT SEVERE MITRAL VALVE REGURGITATION WAS OBSERVED ON A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). IT WAS STATED THAT THE RING WAS OBSERVED TO BE IN A CORRECT AND STABLE POSITION. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IS SCHEDULED TO BE PERFORMED IN THE NEXT MONTH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20693080 ↗
• InjuryMar 23, 2020Adverse 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 DURING THE IMPLANT OF THIS 40MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A N ON-MEDTRONIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9866340 ↗
• InjuryApr 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8528736 ↗
• InjuryDec 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE DEVICE WAS REPLACED WITH ANOTHER MITRAL ANNULOPLASTY BAND FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8150840 ↗
• InjuryApr 19, 2017Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE WAS EXPLANTED IMMEDIATELY POST IMPLANT. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6503713 ↗
• InjuryApr 2, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION FROM THIS PHYSICIAN THAT THIS DEVICE WAS IMPLANTED AND EXPLANTED IN THE SAME PROCEDURE BECAUSE THE RING WAS TOO SMALL. THE DEVICE WAS REPLACED WITH ANOTHER ANNULOPLASTY RING. THERE WERE NO RING RELATED PROBLEMS, AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6452031 ↗