SimuForm™ 7800RR38 (UDI 00763000271237)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000271237), received between Mar 11, 2021 and Jul 17, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryNov 21, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 MONTH POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE P2 SCALLOP OF THE POSTERIOR LEAFLET WAS PROLAPSED, LEADING TO RECURRENT SEVERE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Prolapse

  MAUDE report 20747147 ↗
• InjuryNov 22, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS 38MM ANNULOPLASTY RING, IT WAS EXPLANTED. THE REASON FOR THE EXPLANT WAS INDICATED TO BE DUE TO A SIZING ISSUE AS IT WAS REPORTED THAT A SMALLER RING WAS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 15844701 ↗
• InjuryNov 9, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 36MM RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS BEING DUE TO A SIZING ADJUSTMENT.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15759760 ↗
• InjuryFeb 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED DURATION POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENTEFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13471793 ↗
• InjuryMar 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN ANNULOPLASTY RING OF A DIFFERENT MODEL. IT WAS REPORTED THAT THE PATIENT'S NATIVE VALVE HAD EXTRA ANNULAR TISSUE, AND THE PHYSICIAN BELIEVED THAT A FLEXIBLE RING WOULD BE MORE ADEQUATE FOR THE PATIENT'S TISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11461541 ↗