Simulus™ 800SC36Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169182141), received between May 3, 2017 and Sep 25, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Insufficient Device Problem Information

  Medtronic received information that 5 months post implant of this 36mm mitral annuloplasty band, it was explanted and replaced with a 30mm mitral annuloplasty band 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 50896364 ↗
• InjuryDec 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 YEARS AND 1 MONTH POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY HEART-BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME(SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23691238 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 5 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS SUSTAINED VENTRICULAR TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tachycardia

  MAUDE report 23280601 ↗
• InjuryMay 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS POST IMPLANT OF THIS 36MM SIMULUS BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22083463 ↗
• InjuryFeb 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 4 MONTHS POST IMPLANT OF THIS 36MM SIMULUS MITRAL BAND, IT WAS EXPLANTED AND REPLACED WITH A 36MM SIMUPLUS MITRAL BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21469514 ↗
• InjuryMay 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 4 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19297903 ↗
• InjuryMar 25, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE MITRAL REGURGITATION AND RUPTURED CHORDAE TEN DENEAE. IT WAS ALSO REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED WITH A 36MM MITRAL ANNULOPLASTY BAND OF A DIFFERENT MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18967123 ↗
• InjuryDec 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 36MM ANNULOPLASTY BAND OF DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18291345 ↗
• InjuryFeb 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1YEAR 8 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 34MM MITRAL ANNULOPLASTY BAND 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 16303242 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 51 DAYS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS BRADY/TACHY SYNDROME AND SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 11973853 ↗
• InjuryFeb 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31 MM VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11265262 ↗
• InjuryOct 18, 2019Inadequacy 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 36MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9208403 ↗
• InjuryMay 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. THE REASON FOR EXPLANT IS UNKNOWN. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6540443 ↗