Tri-Ad™ 900SFC232Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000102333), received between Apr 23, 2021 and Mar 18, 2026 — classified as 2 deaths, 12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND ON THE SAME DAY, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 24625569 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 YEARS AND 5 MONTHS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND AND A 42MM MITRAL ANNULOPLASTY BAND, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PALPITATIONS AND CHEST PAIN AND WAS FOUND TO BE IN ATRIAL FIBRILLATION WITH A RAPID VENTRICULAR RATE (RVR). IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ANTIARRHYTHMIC MEDICATIONS AND 1 DAY LATER, CONVERTED TO NORMAL SINUS RHYTHM. IT WAS STATED THAT AN ANTIARRHYTHMIC MEDICATION WAS DISCONTINUED DUE TO RECURRENCE OF ATRIAL FIBRILLATION WITH ELEVATED LIVER FUNCTION TESTS. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Chest Pain

  MAUDE report 23301837 ↗
• InjuryJun 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 MONTHS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 30MM ANNULOPLASTY BAND 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 22195189 ↗
• InjuryMar 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT INDICATED THAT A PATIENT THAT WAS IMPLANTED WITH A 27MM BIOPROSTHETIC VALVE, 31MM BIOPROSTHETIC VALVE AND 32MM TRICUSPID ANNULOPLASTY BAND ALSO HAD A PERMANENT PACEMAKER OF A DIFFERENT MANUFACTURER IMPLANTED. THE REASON FOR THEPERMANENT PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21570797 ↗
• DeathFeb 20, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE CAUSE OF DEATH AS NON-SUDDEN CARDIAC DEATH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 21421284 ↗
• InjuryNov 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND, 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 20622867 ↗
• InjurySep 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 1 MONTH POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND, 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 20148213 ↗
• InjuryJul 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE AND 32MM TRICUSPID ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 19678934 ↗
• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND, THE PATIENT HAD THEIR PACEMAKER AND LEADS REPLACED. THE REASON FOR THE REPLACEMENT WAS REPORTED AS "INFECTED VALVES". NO INTERVENTION OF THE ANNULOPLASTY BAND WAS REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16853691 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 2 WEEKS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND, THE PATIENT EXPERIENCED TORSADE'S DE POINTES AND VENTRICULAR FIBRILLATION. IT WAS STATED THAT THE PATIENT WAS "DEFIBBED". IT WAS ALSO REPORTED THAT ONE DAY PRIOR TO THIS, THE PATIENT ALSO EXPERIENCED RESPIRATORY FAILURE AND A TRACHEOSTOMY WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Respiratory Failure; Ventricular Fibrillation

  MAUDE report 16725782 ↗
• InjuryJun 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 28MM BAND 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 14829591 ↗
• InjuryApr 6, 2022Adverse 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 32MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 14021754 ↗
• InjuryAug 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS AND 16 DAYS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12355923 ↗
• DeathApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY BAND, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE ANNULOPLASTY BAND OR ITS FUNCTION CONTRIBUTED TO THE PATIENTS DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 11720183 ↗