Simulus™ 800SR26Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169182103), received between Jun 14, 2017 and Feb 18, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY RING, IT 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: Insufficient Information

  MAUDE report 24376200 ↗
• InjuryJul 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 4 MONTHS POST IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY RING, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22375602 ↗
• InjuryJul 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 MONTHS POST IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY RING, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY AND NEW YORK HEART ASSOCIATON (NYHA) CLASS II. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy; Non specific EKG/ECG Changes

  MAUDE report 22375261 ↗
• InjuryMay 23, 2025Material Separation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Material Separation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS POST IMPLANT OF THIS 26MM SIMULUS SR MITRAL RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM MOSAIC MITRAL VALVE. 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 22076508 ↗
• InjuryOct 20, 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 26MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 25MM MITRAL BIOPROSTHETIC VALVE DUE TO RESIDUAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS RELATED TO THE MITRAL ANNULOPLASTY RING WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 12669011 ↗
• InjuryMar 31, 2020Inadequacy 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 DURING THE IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY RING, IT 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 9903308 ↗
• InjuryAug 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8903754 ↗
• InjuryJul 17, 2019Adverse 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 IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR EXPLANT OF THE RING WAS NOT PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Tissue Damage

  MAUDE report 8800294 ↗
• InjuryJul 25, 2018Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS 26MM ANNULOPLASTY RING, THE VALVE REPAIR WAS TESTED WITH SALINE AND REGURGITATION WAS STILL PRESENT. THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; Regurgitation

  MAUDE report 7720504 ↗
• InjuryApr 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 26 MM ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7430218 ↗
• InjuryMar 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING AN IMPLANT, THIS ANNULOPLASTY RING WAS IMPLANTED AND SUBSEQUENTLY EXPLANTED. THE REASON FOR EXPLANT WAS DUE TO THE PHYSICIAN ELECTING TO REPLACE THE VALVE INSTEAD OF REPAIR. THE PHYSICIAN INDICATED THERE WERE NO MALFUNCTIONS OF THE PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7371603 ↗
• InjuryDec 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 26MM ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED. THE REASON FOR EXPLANT WAS NOT REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Known Impact Or Consequence To Patient

  MAUDE report 7133809 ↗
• InjuryOct 12, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE PROCEDURE TO IMPLANT THIS 26MM ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED. THE PHYSICIAN STATED THE SIZE WAS TOO BIG TO ADEQUATELY SHRINK ANNULUS FOR PROPER COAPTATION OF LEAFLETS AND DID NOT RESOLVE THE MITRAL REGURGITATION (MR). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 6944688 ↗
• InjuryAug 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Information

  MAUDE report 6823871 ↗
• InjuryAug 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED THE SAME DAY DUE TO MITRAL INSUFFICIENCY. THE DEVICE WAS REPLACED WITH A BIOPROSTHETIC VALVE. THERE WERE NO REPORTED ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: Mitral Insufficiency

  MAUDE report 6778683 ↗
• InjuryJun 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING POST IMPLANT OF THIS ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6640978 ↗