Simulus™ 700FC25Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169182400), received between Jul 31, 2017 and Feb 21, 2025 — classified as 1 death, 12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS 25 MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT HAD SEVERE TRICUSPID REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 21433237 ↗
• InjuryFeb 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 27 MM MITRAL MECHANICAL VALVE AND 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS 25 MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEIZURE ACTIVITY AND A STROKE. A COMPUTED TOMOGRAPHY (CT) OF THE HEAD DEMONSTRATED NO ACUTE PROCESS. AN ELECTROENCEPHALOGRAPHY SHOWED STATUS EPILEPTICUS AND A ANTI-EPILEPTIC DRUG WAS ADMINISTERED. IT WAS STATED THAT THE COMPUTED TOMOGRAPHY (CT) SHOWED THE PRESENCE OF A RIGHT M2 BRANCH OCCLUSION, A RELATIVELY SMALL BRANCH DISTAL TO A TRIFURCATION OF THE MIDDLE CEREBRAL ARTERY (MCA), WITH IMMEDIATE DISTAL RECONSTITUTION AND SHOWED A REGION OF MODERATE STENOSIS OF RIGHT M2 BRANCHES WITH POST-STENOTIC DILATATION. AN MAGNETIC RESONANCE IMAGING (MRI) OF THE HEAD WAS OBTAINED THE FOLLOWING DAY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Convulsion/Seizure; Stroke/CVA

  MAUDE report 21433235 ↗
• InjuryApr 11, 2024Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 4 MONTHS POST IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19092817 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR CONVERSION FROM ATTEMPTED VALVE REPAIR TO COMPLETE VALVE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 9513477 ↗
• InjuryOct 4, 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 THIS 25MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 9156675 ↗
• DeathJun 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 25MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE BAND WAS REPLACED WITH A 25MM BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8682818 ↗
• InjuryJun 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE BECAUSE THE PATIENT'S VALVE WAS UNABLE TO BE REPAIRED. THERE WERE NO ISSUES REPORTED WITH THE ANNULOPLASTY BAND. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8663730 ↗
• InjuryMay 8, 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 BAND, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR CONVERSION FROM VALVE REPAIR TO VALVE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8592874 ↗
• InjuryApr 18, 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 BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8528825 ↗
• InjuryMay 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR EXPLANT WAS REPORTED AS RECURRENT SEVERE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7493350 ↗
• InjuryDec 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE DUE TO INSUFFICIENCY OF THE ANNULOPLASTY BAND. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficiency, Valvular

  MAUDE report 7141783 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Calcium Deposits/Calcification; No Information

  MAUDE report 7107692 ↗
• InjuryJul 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Information

  MAUDE report 6755773 ↗