Tri-Ad™ 900SFC28Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169195356), received between Jun 28, 2017 and Mar 23, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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.

• InjuryMar 23, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 10 YEARS AND 7 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING IMPLANTED IN THE AORTIC POSITION, A 26MM AORTIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24660599 ↗
• InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 6 YEARS AND 7 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID HEART RING, IT WAS EXPLANTED AND REPLACED WITH A 26MM  TRICUSPID HEART RING OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23665521 ↗
• InjuryApr 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 1 MONTH POST IMPLANT OF THIS 28 MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16702185 ↗
• InjuryMay 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 10 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11843487 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING AND THIS 29MM BIOPROSTHETIC MITRAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PERMANENT PACEMAKER IMPLANT WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 9334977 ↗
• InjurySep 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH AND 18 DAYS POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION. THE REASON FOR REPLACEMENT WAS DUE TO PERSISTENT REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Regurgitation

  MAUDE report 9116432 ↗
• InjuryAug 27, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8935542 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE PATIENT EXPIRED 8 DAYS POST IMPLANT OF THE BIOPROSTHETIC VALVE. THE CAUSE OF DEATH WAS NOT REPORTED, AND IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: No Information

  MAUDE report 8930876 ↗
• InjuryJul 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS PATIENT'S TRICUSPID VALVE WAS ATTEMPTED TO BE REPAIRED WITH A TRICUSPID ANNULOPLASTY RING. IMMEDIATELY POST IMPLANT, THE RING WAS EXPLANTED FOR UNKNOWN REASONS AND A BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Information

  MAUDE report 8751527 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND AND TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO TACHY-BRADY SYNDROME, ATRIAL FIBRILLATION (AFIB), AND ATRIAL FLUTTER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Bradycardia; Non specific EKG/ECG Changes

  MAUDE report 8704807 ↗
• InjurySep 11, 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 THIS 28MM ANNULOPLASTY RING WAS IMPLANTED AND SUBSEQUENTLY EXPLANTED DURING THE SAME PROCEDURE. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7865479 ↗
• InjuryAug 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN VALVE. THE PHYSICIAN REPORTED THE REPAIR WAS INSUFFICIENT AND A COMPLETE VALVE REPLACEMENT WAS NECESSARY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7806002 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR 10 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, THE DEVICE WAS EXPLANTED AND REPLACED WITH A 29MM TRICUSPID BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7070628 ↗
• InjurySep 22, 2017Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT THIS TRICUSPID ANNULOPLASTY RING WAS "WASTED AND REMOVED" ON THE DAY OF IMPLANT. THE REASON FOR THE EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6888502 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION APPROXIMATELY FOUR DAYS POST-IMPLANT OF THIS ANNULOPLASTY RING IN THE TRICUSPID POSITION, THE PATIENT RECEIVED A PACEMAKER PLACED BEFORE LEAVING HOSPITAL BECAUSE OF A CHANGE IN THE PATIENT'S HEART RHYTHM DUE TO A "SURGICAL ERROR." APPROXIMATELY ONE YEAR POST-IMPLANT, THE PATIENT WILL RECEIVE A DEFIBRILLATOR IMPLANT BECAUSE HER "ECHO AND RHYTHM HAVE WORSENED." NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 6674041 ↗