SimuForm™ 7800RR30 (UDI 00763000271497)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000271497), received between Jun 7, 2022 and Jul 3, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryJan 6, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION REPORTED THAT THE REASON FOR INTERVENTION WAS MITRAL REGURGITATION (MR) AND THE ANNULOPLASTY PRODUCT WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23974815 ↗
• InjuryNov 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 8 DAYS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY HEART RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITR AL BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23522470 ↗
• InjuryAug 1, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM SIMUFORM ANNULOPLASTY HEART RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN COMPETITORS PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22684854 ↗
• InjuryJul 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 12 DAYS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, 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 19743038 ↗
• InjuryJul 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING AND 23MM AORTIC BIOPROSTHETIC VALVE, A REPLACEMENT 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 19708489 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, AN ELECTROCARDIOGRAM (ECG) NOTED 2ND DEGREE ATRIOVENTRICULAR (AV) BLOCK .  IT WAS REPORTED THAT ONE DAY LATER, THE PATIENT WAS TREATED BY STOPPING THEIR MEDICATION (AMIODARONE) AND PACED WITH AN EPICARDIAL PACEMAKER FOR 3 DAYS. IT WAS REPORTED THAT THE EVENT RESOLVED AND THE PATIENT RECOVERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18906177 ↗
• InjuryDec 7, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 28MM 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 15933969 ↗
• InjuryJun 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14622391 ↗