Simulus™ 800SC30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169182172), received between Sep 26, 2017 and Feb 20, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 14 DAYS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS) AND ATRIAL ARRHYTHMIAS ((ATRIAL TACHYCARDIA (AT). ATRIAL FIBRILLATION (AF) AND ATRIAL FLUTTER (A-FL)). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Tachycardia

  MAUDE report 24400358 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT 2 YEARS AND 4 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 3 0MM MITRAL ANNULOPLASTY BAND OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24321342 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 7 MONTHS POST IMPLANT OF THIS 30MM 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 24159405 ↗
• InjurySep 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 10 MONTHS POST IMPLANT OF THESE TRI-AD AND SIMULUS HEART BANDS, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASONS FOR THE PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA, SICK SINUS SYNDROME (SSS), ATRIAL FIBRILLATION, ATRIAL FLUTTER AND ATRIAL TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23083574 ↗
• InjuryDec 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE 30MM MITRAL ANNULOPLASTY BAND WAS REPLACED DUE TO FAILED REPAIR AND NEED FOR VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20847366 ↗
• InjuryOct 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 WEEKS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 20384834 ↗
• InjurySep 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS ANNULOPLASTY BAND, THE BAND WAS EXPLANTED DUE TO RESIDUAL MITRAL REGURGITATION AND REPLACED WITH AN ANNULOPLASTY RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 6894793 ↗