Simulus™ 800SR24Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169182110), received between Jun 23, 2017 and Jan 22, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Burst Container or Vessel

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO IMPACT TO THE PATIENT ASSOCIATED WITH THIS EVENT. NO CAUSE OR CONTRIBUTING FACTOR WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24157995 ↗
• InjuryMay 16, 2025Thickening of Material; Intravalvular regurgitation; Thickening of Material; Intravalvular regurgitation

  IT WAS REPORTED THAT POST IMPLANT OF THIS 24MM SIMULUS MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC MECHANICAL VALVE DUE TO MODERATE TO SEVERE MITRAL REGURGITATION. IT WAS STATED THAT DURING THE EXPLANT PROCEDURE, IT WAS NOTED THAT THE 24MM SIMULUS MITRAL ANNULOPLASTY RING WAS DEHISCED SPECIFICALLY AT THE AREA OF P2 AND P3, SIGNIFICANTLY SCARRED DOWN, THICKENED AND APPEARED TO EXHIBIT RHEUMATIC CHANGES. IT WAS REPORTED THAT PRIOR TO EXPLANT, THE PATIENT DEVELOPED SIGNIFICANT SHORTNESS OF BREATH AND WAS FOUND TO HAVE SEVERE BIVALVULAR DYSFUNCTION IN THE SETTING OF MASSIVE VOLUME OVERLOAD WITH LEFT VENTRICULAR EJECTION FRACTION OF 50% TO 55%. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22034976 ↗
• InjuryApr 4, 2025Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT A NEW VALVE WAS IMPLANTED IN THE MITRAL POSITION ON (B)(6) 2025. THE OLD VALVE WAS EXPLANTED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21773379 ↗
• InjuryJan 8, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

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

  Patient problems: Insufficient Information; Mitral Valve Stenosis

  MAUDE report 21106455 ↗
• InjuryFeb 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 24MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13440770 ↗
• InjuryDec 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 24 MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11051129 ↗
• InjuryApr 3, 2019Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT TWO YEARS 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: Dyspnea; Mitral Regurgitation; Mitral Valve Stenosis; No Information

  MAUDE report 8480084 ↗
• InjuryJun 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS ANNULOPLASTY RING IN THE MITRAL POSITION, THIS DEVICE WAS EXPLANTED AND REPLACED. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6664082 ↗