SimuFormRecalls & reported problems across all models

We found 15 models of SimuForm by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 104 adverse event reports in the FDA's MAUDE database, received between Oct 16, 2020 and Jul 20, 2026 — classified as 101 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (53 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 SimuForm problems

SimuForm models

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

• SimuForm™ 7800RR32

  RING, ANNULOPLASTY
  15 reports
• SimuForm™ 7800RR34

  RING, ANNULOPLASTY
  13 reports
• SimuForm™ 7800RR26

  RING, ANNULOPLASTY
  12 reports
• SimuForm™ 7800RR30

  RING, ANNULOPLASTY
  11 reports
• SimuForm™ 7800RR30

  RING, ANNULOPLASTY
  10 reports
• SimuForm™ 7800RR32

  RING, ANNULOPLASTY
  8 reports
• SimuForm™ 7800RR34

  RING, ANNULOPLASTY
  8 reports
• SimuForm™ 7800RR28

  RING, ANNULOPLASTY
  7 reports
• SimuForm™ 7800RR38

  RING, ANNULOPLASTY
  6 reports
• SimuForm™ 7800RR36

  RING, ANNULOPLASTY
  3 reports
• SimuForm™ 7800RR40

  RING, ANNULOPLASTY
  3 reports
• SimuForm™ 7800RR28

  RING, ANNULOPLASTY
  3 reports
• SimuForm™ 7800RR36

  RING, ANNULOPLASTY
  3 reports
• SimuForm™ 7800RR26

  RING, ANNULOPLASTY
  1 report
• SimuForm™ 7800RR38

  RING, ANNULOPLASTY
  1 report

Recent SimuForm adverse event reports

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

• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 3 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25870587 ↗
• InjuryJul 17, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 1 YEAR AND 10 MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25854293 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 36MM MITRAL ANNULOPLASTY RING 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 25822703 ↗
• MalfunctionJul 9, 2026Incomplete Coaptation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ANNULOPLASTY PRODUCT MALFUNCTION DID NOT MALFUNCTION AND IT WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25759971 ↗
• InjuryJul 3, 2026Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM SIMUFORM SR ANNULOPLASTY HEART RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL REGURGITATION (MR). AFTER THE RING WAS IMPLANTED, A SALINE TEST SHOWED POOR REPAIR WITH REGURGITATION, AND THE DEVICE WAS THEREFORE REMOVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 25703818 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 30 MM 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 25407717 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34 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 25241424 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 34MM 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 25239621 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 24 MM 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 25056413 ↗
• MalfunctionApr 20, 2026Structural Problem; Incomplete Coaptation

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE REASON FOR INTERVENTION WAS DUE TO COAPTATION. THE ANNULOPLASTY PRODUCT WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL AND THE DEVICE DID MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24925741 ↗
• InjuryApr 1, 2026Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM SIMUFORM ANNULOPLASTY HEART RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM MOSAIC MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL REGURGITATION (MR). IT WAS REPORTED THAT INTRAOPERATIVE TESTS WERE SUBOPTIMAL, WITH PERSISTENT REGURGITATION. AFTER EVALUATION BY THE SURGEON, THE VALVE WAS REPLA CED. THE ANNULOPLASTY PRODUCT WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24752103 ↗
• InjuryMar 16, 2026Fluid/Blood Leak; Incomplete Coaptation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR REPLACEMENT OF THIS MITRAL ANNULOPLASTY RING WAS DUE TO COAPTATION. THE DEVICE WAS FULLY SUTURED AND TESTED TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 24606176 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 32MM 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 24579202 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT WAS DUE TO PATIENT ANATOMY, AND NOT THE ANNULOPLASTY RING. IT WAS FURTHER REPORTED THAT THE ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A VALVE PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24305562 ↗
• InjuryJan 21, 2026Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED SUBSEQUENTLY, AN UNKNOWN DURATION LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE -IN-RING. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24129981 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls