SimuPlusRecalls & reported problems across all models

We found 24 models of SimuPlus by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 162 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2020 and Jul 17, 2026 — classified as 1 death, 159 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (92 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SimuPlus problems

SimuPlus models

24 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SimuPlus™ 7700FB36

  RING, ANNULOPLASTY
  1 death26 reports
• SimuPlus™ 7700FB30

  RING, ANNULOPLASTY
  17 reports
• SimuPlus™ 7700FB34

  RING, ANNULOPLASTY
  16 reports
• SimuPlus™ 7700FB32

  RING, ANNULOPLASTY
  15 reports
• SimuPlus™ 7700FB38

  RING, ANNULOPLASTY
  13 reports
• SimuPlus™ 7700FB42

  RING, ANNULOPLASTY
  10 reports
• SimuPlus™ 7700FB32

  RING, ANNULOPLASTY
  9 reports
• SimuPlus™ 7700FB28

  RING, ANNULOPLASTY
  9 reports
• SimuPlus™ 7700FB26

  RING, ANNULOPLASTY
  8 reports
• SimuPlus™ 7700FB36

  RING, ANNULOPLASTY
  5 reports
• SimuPlus™ 7700FB42

  RING, ANNULOPLASTY
  5 reports
• SimuPlus™ 7700FB40

  RING, ANNULOPLASTY
  5 reports
• SimuPlus™ 7700FB30

  RING, ANNULOPLASTY
  4 reports
• SimuPlus™ 7700FB28

  RING, ANNULOPLASTY
  3 reports
• SimuPlus™ 7700FB34

  RING, ANNULOPLASTY
  3 reports
• SimuPlus™ 7700FB26

  RING, ANNULOPLASTY
  2 reports
• SimuPlus™ 7700FB38

  RING, ANNULOPLASTY
  2 reports
• SimuPlus™ 7700FB40

  RING, ANNULOPLASTY
  2 reports
• SimuPlus™ 7700FR38

  RING, ANNULOPLASTY
  2 reports
• SimuPlus™ 7700FR32

  RING, ANNULOPLASTY
  2 reports
• SimuPlus™ 7700FR30

  RING, ANNULOPLASTY
  1 report
• SimuPlus™ 7700FR34

  RING, ANNULOPLASTY
  1 report
• SimuPlus™ 7700FR34

  RING, ANNULOPLASTY
  1 report
• SimuPlus™ 7700FR36

  RING, ANNULOPLASTY
  1 report

Recent SimuPlus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTHS POST IMPLANT OF THIS 26MM TRCUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 30MM TRCUSPID 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 25855206 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 32MM 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 25407671 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 38MM 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 25239624 ↗
• InjuryMay 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS RESIDUAL REGURGITATION. IT WAS REPORTED THAT THE ANNULOPLASTY PRODUCT DID MALFUNCTION AND THE DEVICE WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. IT WAS ALSO NOTED THAT THE PATIENT DID HAVE PRE-EXISTING CONDITIONS/ANATOMICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 25147488 ↗
• InjuryMay 12, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 4 DAYS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC M ITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 25146541 ↗
• InjuryMay 7, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH 32MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL REGURGITATION. IT WAS REPORTED THAT THE ANNULOPLASTY PRODUCT DID NOT MALFUNCTION AND WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. IT WAS ALSO NOTED THAT THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS/ANATOMICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 25109241 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 28MM 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 25056382 ↗
• InjuryApr 28, 2026Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERITY OF RESIDUAL REGURGITATION WAS MODERATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 25012375 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT 11 MONTHS POST IMPLANT OF THIS 28MM MITRAL HEART BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM 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 24952796 ↗
• InjuryApr 21, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MILD-MODERATE MITRAL REGURGITATION (MR). IT WAS ALSO NOTED THAT THE PATIENT WAS FOUND TO HAVE A LARGE RIGHT PLEURAL EFFUSION WHICH WAS DRAINED DURING SURGERY. THE DEVICE WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Pleural Effusion

  MAUDE report 24940064 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1 YEARS AND 3 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 38MM 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 24815201 ↗
• InjuryApr 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 42MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24765759 ↗
• InjuryMar 25, 2026Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS/ANATOMICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24684912 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 10  MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24520301 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 30MM 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 24468428 ↗

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