SimulusRecalls & reported problems across all models

We found 40 models of Simulus by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 493 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2016 and Sep 25, 2026 — classified as 3 deaths, 485 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (337 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

Simulus recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 14, 2020Open, Classified

   Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.

   Z-1450-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jan 14, 2020Open, Classified

   Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.

   Z-1449-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Simulus problems

Simulus models

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

• Simulus™ 750

  SIZER, HEART-VALVE, PROSTHESIS
  1 recall0 reports
• Simulus™ 850

  SIZER, HEART-VALVE, PROSTHESIS
  1 recall0 reports
• Simulus™ 800SR30

  RING, ANNULOPLASTY
  43 reports
• Simulus™ 800SR34

  RING, ANNULOPLASTY
  36 reports
• Simulus™ 700FC29

  RING, ANNULOPLASTY
  36 reports
• Simulus™ 700FC31

  RING, ANNULOPLASTY
  34 reports
• Simulus™ 700FC27

  RING, ANNULOPLASTY
  32 reports
• Simulus™ 700FC33

  RING, ANNULOPLASTY
  30 reports
• Simulus™ 800SR28

  RING, ANNULOPLASTY
  29 reports
• Simulus™ 800SR32

  RING, ANNULOPLASTY
  1 death28 reports
• Simulus™ 800SR36

  RING, ANNULOPLASTY
  19 reports
• Simulus™ 800SR26

  RING, ANNULOPLASTY
  16 reports
• Simulus™ 800SR38

  RING, ANNULOPLASTY
  16 reports
• Simulus™ 700FC35

  RING, ANNULOPLASTY
  15 reports
• Simulus™ 700FF29

  RING, ANNULOPLASTY
  15 reports
• Simulus™ 800SC36

  RING, ANNULOPLASTY
  13 reports
• Simulus™ 700FC25

  RING, ANNULOPLASTY
  1 death13 reports
• Simulus™ 700FC37

  RING, ANNULOPLASTY
  1 death11 reports
• Simulus™ 800SC34

  RING, ANNULOPLASTY
  10 reports
• Simulus™ 800SC28

  RING, ANNULOPLASTY
  10 reports
• Simulus™ 700FC23

  RING, ANNULOPLASTY
  10 reports
• Simulus™ 800SR40

  RING, ANNULOPLASTY
  9 reports
• Simulus™ 800SR24

  RING, ANNULOPLASTY
  8 reports
• Simulus™ 700FC39

  RING, ANNULOPLASTY
  8 reports
• Simulus™ 800SC30

  RING, ANNULOPLASTY
  7 reports
• Simulus™ 700FF27

  RING, ANNULOPLASTY
  7 reports
• Simulus™ 800SC32

  RING, ANNULOPLASTY
  6 reports
• Simulus™ 700FF31

  RING, ANNULOPLASTY
  6 reports
• Simulus™ 700FF25

  RING, ANNULOPLASTY
  5 reports
• Simulus™ 700FF33

  RING, ANNULOPLASTY
  5 reports
• Simulus™ 800SC24

  RING, ANNULOPLASTY
  3 reports
• Simulus™ 800SC38

  RING, ANNULOPLASTY
  2 reports
• Simulus™ 800SC26

  RING, ANNULOPLASTY
  2 reports
• Simulus™ 700FF37

  RING, ANNULOPLASTY
  2 reports
• Simulus™ 700FF35

  RING, ANNULOPLASTY
  2 reports
• Simulus™ 800SC40

  RING, ANNULOPLASTY
  1 report
• Simulus™ 735AF37

  RING, ANNULOPLASTY
  1 report
• Simulus™ 700FF23

  RING, ANNULOPLASTY
  1 report
• Simulus™ 700FF39

  RING, ANNULOPLASTY
  1 report
• Simulus™ 735AC35

  RING, ANNULOPLASTY
  1 report

Recent Simulus adverse event reports

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

• InjurySep 25, 2026Insufficient Device Problem Information

  Medtronic received information that 5 months post implant of this 36mm mitral annuloplasty band, it was explanted and replaced with a 30mm 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 50896364 ↗
• 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 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 2 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 35MM MITRAL ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25822916 ↗
• InjuryJun 4, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 YEARS AND 8 MONTHS POST IMPLANT OF THIS 33 MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25391044 ↗
• MalfunctionMay 28, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 5 YEARS POST IMPLANT OF THIS 32MM ANNULOPLASTY RING, IT WAS REPORTED THAT A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED NOTED MODERATE TRICUSPID REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 25313573 ↗
• 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 ↗
• InjuryMay 15, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 7 YEARS AND 2 MONTHS POST IMPLANT OF THIS 29 MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS BRADYCARDIA-TACHYCARDIA SYNDROME. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 25184007 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT 7 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A N ON-MEDTRONIC DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25123182 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 8 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 24536532 ↗
• InjuryFeb 24, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 YEARS AND 9 MONTHS POST IMPLANT OF THIS 33MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 24428721 ↗
• InjuryFeb 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 14 DAYS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS) AND ATRIAL ARRHYTHMIAS ((ATRIAL TACHYCARDIA (AT). ATRIAL FIBRILLATION (AF) AND ATRIAL FLUTTER (A-FL)). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Tachycardia

  MAUDE report 24400358 ↗
• 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 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT 2 YEARS AND 4 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 3 0MM MITRAL ANNULOPLASTY BAND OF A DIFFERENT MODEL. 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 24321342 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 7 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 30MM 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 24159405 ↗
• 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 ↗

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