Tri-Ad™ 900SFC32Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169195370), received between Apr 3, 2017 and Nov 18, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 YEARS AND 5 MONTHS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY HEART RING, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS SYNCOPE WITH INDUCIBLE VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting; Tachycardia; Ventricular Fibrillation

  MAUDE report 23580474 ↗
• InjuryJun 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS TRI-AD RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA, ATRIAL TACHYCARDIA, ATRIAL FIBRILLATION AND ATRIAL FLUTTER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Bradycardia; Tachycardia

  MAUDE report 22156703 ↗
• InjuryMay 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT A 32MM ANNULOPLASTY HEART BAND WAS IMPLANTED IN THE TRICUSPID POSITION AND EXPLANTED ON THE-SAME DAY. IT WAS ALSO REPORTED THAT A REPLACEMENT WAS DONE USING A 33MM BIOPROSTHETIC HEART VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10102850 ↗
• InjuryMar 25, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THERE WERE NO ALLEGATIONS AGAINST THE RING OR ITS FUNCTION. THE PHYSICIAN REPORTED PATIENT ANATOMY ISSUES AND DETERMINED REPLACING THE VALVE WOULD BE BETTER FOR THE PATIENT. NO ADDITIONAL ADVERSE PATIENT WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9877383 ↗
• InjuryMay 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 8647446 ↗
• InjuryJun 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM ANNULOPLASTY RING IN THE TRICUSPID POSITION, THE RING WAS EXPLANTED AND REPLACED FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Tricuspid Regurgitation

  MAUDE report 7635016 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR IMPLANT OF A PERMANENT PACEMAKER IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Non specific EKG/ECG Changes

  MAUDE report 7514394 ↗
• InjuryMay 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS ANNULOPLASTY RING IT WAS REPLACED WITH A BIOPROSTHETIC VALVE DUE TO POOR ECHOCARDIOGRAM RESULTS. THE PHYSICIAN EXPRESSED DISSATISFACTION WITH THE RING. NO SPECIFIC FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6589295 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ONE YEAR, FOUR MONTHS POST IMPLANT OF THIS ANNULOPLASTY RING IN THE TRICUSPID POSITION, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC MITRAL VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Organ Dehiscence

  MAUDE report 6556283 ↗
• InjuryApr 3, 2017Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, THIS DEVICE WAS EXPLANTED. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Tricuspid Regurgitation

  MAUDE report 6453674 ↗