SimuForm™ 7800RR32 (UDI 00763000271503)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000271503), received between Jun 7, 2022 and Jul 9, 2026 — classified as 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 8, 2026Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM SIMUFORM HEART RING, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED THAT AFTER IMPLANTATION, IMMEDIATE POSTOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED THAT THE ANTERIOR RING DID NOT MOVE WITH THE ANTERIOR MITRAL LEAFLET, AFFECTING LEAFLET COAPTATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24002355 ↗
• InjuryOct 15, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE ANNULOPLASTY RING WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. THE REPLACEMENT DEVICE WAS ALSO CONFIRMED TO BE THE SAME 32MM SIZE OF THE ANNULOPLASTY RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23278097 ↗
• InjurySep 11, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE DOES NOT APPEAR TO HAVE ANY MALFUNCTIONS OR DAMAGES PRIOR TO USE AND WAS WAS FULLY SUTURED AND TESTED BEFORE REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23027089 ↗
• InjuryJun 26, 2025Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 32MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED ON THE SAME DAY DURING A PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22338565 ↗
• InjurySep 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 1 MONTH POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK, ATRIAL ARRHYTHMIAS AND SINUS NODE DYSFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block; Non specific EKG/ECG Changes

  MAUDE report 20148156 ↗
• InjuryMay 27, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT AORTIC REGURGITATION (AR) AND MITRAL REGURGITATION (MR) WERE OBSERVED ON A ECHOCARDIOGRAM. A TRANSCATHETER AORTIC VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19400025 ↗
• InjuryApr 25, 2024Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR PROVIDED THE DEVICE UNIQUE DEVICE IDENTIFIER (SERIAL NUMBER (B)(6) AND THE PATIENT'S WEIGHT OF 54 KG. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19188636 ↗
• InjuryMar 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM 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 18922026 ↗
• InjuryJan 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS DUE TO THE PATIENT'S ANATOMY AND MILD TO MODERATE MITRAL REGURGITATION AT THE MEDIAL COMMISSURE. IT WAS NOTED THAT DURING THIS PROCEDURE, AN ASCENDING AORTA REPLACEMENT WITH REPLACEMENT OF THE NON-CORONARY SINUS AND AN AORTIC VALVE REPLACEMENT WAS ALSO PERFORMED. IT WAS REPORTED THAT POST IMPLANT OF THE MITRAL RING AND OF ANOTHER MANUFACTURERS VASCULAR GRAFT AND AORTIC BIOPROSTHETIC VALVE, THE PATIENT EXPERIENCED A JUNCTIONAL RHYTHM FOLLOWED BY VENTRICULAR TACHYCARDIA (V-TACH) WHICH WAS TREATED WITH DEFIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Tachycardia

  MAUDE report 18543410 ↗
• 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 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 30MM 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 15933911 ↗
• InjuryAug 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 30MM 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 15317566 ↗
• InjuryJun 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 30MM 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 14622320 ↗