Simulus™ 700FC29Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00643169182387), received between Jan 6, 2017 and Jul 17, 2026 — classified as 36 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (26 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 5 YEARS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, SEVERE MITRAL REGUR GITATION WAS NOTED. THE PATIENT ALLEGED THAT THE HEART BAND MIGHT BE ¿FLOATING AROUND¿ AND EXPRESSED CONCERN ABOUT POSSIBLE MOVEMENT OR DISLODGEMENT, BUT COULD NOT CONFIRM WHETHER IT HAD MOVED OR DISLODGED. THE PATIENT ALSO REPORTED THAT A RECENT TRANSESOPHAGEAL E CHOCARDIOGRAM AND/OR CATHETER-BASED EVALUATION INCLUDED A PHYSICIAN NOTE INDICATING THE HEART BAND WAS ¿TOO SMALL.¿ THE PATIENT STATED THEY PLANNED TO BE EVALUATED BY A NEW CARDIOLOGIST FOR THE ONGOING REGURGITATION AND BELIEVED A HEART VALVE REPLACEMENT MIGHT BE RECOMMENDED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 25855624 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25300595 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 5 YEARS AND 3 MONTHS POST IMPLANT OF THIS 29MM MITRAL/TRICUSPID ANNULOPLASTY BAND IMPLANTED IN THE AORTIC POSITION, IT WAS EXPLANTED AND REPLACED WITH A 25MM AORTIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23875521 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 7 YEARS AND 3 MONTHS POST IMPLANT OF THIS 29MM ANNULOPLASTY BAND, 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 23875430 ↗
• InjuryDec 13, 2024Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT A NEW TISSUE VALVE WAS IMPLANTED IN THE MITRAL POSITION. THE PATIENT HAD AN EXISTING 29MM HEART BAND IMPLANTED IN THE MITRAL POSITION. THE OLD HEART BAND WAS EXPLANTED.

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

  MAUDE report 20924229 ↗
• InjuryFeb 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 28MM 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 16413246 ↗
• InjuryDec 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 3 MONTHS POST IMPLANT OF THIS 29MM 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

  MAUDE report 16009429 ↗
• InjuryMar 31, 2022Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL 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

  MAUDE report 13971713 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED TO BE DUE TO INCOMPLETE AV BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 13831835 ↗
• InjuryMar 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 29MM ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13792741 ↗
• InjuryJan 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS RECURRENT MITRAL INSUFFICIENCY. IT WAS ALSO REPORTED THAT THE "STICHES BETWEEN A3 AND P3 WERE TORN" AND THAT THERE WAS A TORN LEAFLET. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 13206587 ↗
• InjuryAug 10, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM 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 12304496 ↗
• InjuryMay 18, 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 MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE ATTEMPTED VALVE REPAIR WAS UNSUCCESSFUL DUE TO THE PATIENT'S ANATOMY. IT WAS NOT RELATED TO THE ANNULOPLASTY DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11841034 ↗
• InjuryMay 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MODERATE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 11777923 ↗
• InjuryMar 26, 2021Adverse 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 DURING THE IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, 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 11575196 ↗
• InjurySep 23, 2020Adverse 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 1 YEAR AND 10 MONTHS POST IMPLANT OF THIS 29 MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29 MM BIOPROSTHETIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10576485 ↗
• InjuryJul 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10239308 ↗
• InjuryJun 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS AN ANTERIOR-DIRECTED JET THROUGH THE PATCHED LEAFLET WHICH RESULTED IN "MORE THAN MODERATE" RESIDUAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 10190119 ↗
• InjuryMar 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aneurysm; Mitral Regurgitation; No Information

  MAUDE report 9774501 ↗
• InjuryNov 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, DUE TO SEVERE REGURGITATION, A 31MM BIOPROSTHETIC VALVE WAS IMPLANTED INSIDE THE RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 9317948 ↗
• InjuryJul 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 29MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE BEFORE BEING REPLACED WITH A NON-MEDTRONIC BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8749147 ↗
• InjuryJun 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS 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 8719293 ↗
• InjuryMar 28, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; 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: Mitral Regurgitation; No Information

  MAUDE report 8459585 ↗
• InjuryFeb 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 ONE YEAR POST IMPLANT OF THIS ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Corneal Pannus; No Information

  MAUDE report 8301582 ↗
• InjuryDec 19, 2018No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ONE MONTH POST IMPLANT OF THIS 29MM ANNULOPLASTY BAND IMPLANTED IN THE TRICUSPID POSITION, THE BAND WAS EXPLANTED AND REPLACED WITH A 28MM ANNULOPLASTY BAND OF A DIFFERENT MODEL FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8181725 ↗