Tri-Ad™ 900SFC228Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00763000102319), received between Aug 12, 2020 and Jul 3, 2026 — classified as 4 deaths, 51 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (26 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 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE IN THE SAME POSITION. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25701639 ↗
• InjuryJun 24, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 6 DAYS POST IMPLANT OF THIS 28MM 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 25609058 ↗
• InjuryMar 17, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 16 DAYS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY HEART BAND, 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 24619367 ↗
• InjuryJan 8, 2026Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 4 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THEY HAD SYMPTOMS OF FATIGUE/TIREDNESS, SHORTNESS OF BREATH AND REGURGITATION. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Fatigue; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24011300 ↗
• InjuryDec 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 9 DAYS POST IMPLANT OF THIS 28MM 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 23776330 ↗
• InjuryDec 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 6 DAYS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR (AVB) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23714355 ↗
• InjuryDec 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DOES NOT BELIEVE THE HEART VALVE OR IMPLANT PROCEDURE CAUSED OR CONTRIBUTED TO THE CONDUCTION DISTURBANCE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 23679380 ↗
• InjuryNov 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 YEARS AND 1 MONTH POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY HEART BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 23508274 ↗
• InjuryOct 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 YEARS AND 1 MONTH POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY HEART BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23412512 ↗
• DeathOct 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE CAUSE OF DEATH AS INTRACEREBRAL HEMORRHAGE. IT WAS FURTHER REPORTED THAT THE INTRACEREBRAL HEMORRHAGE OCCURRED DURING A HYPERTENSIVE EMERGENCY, WHILE ALSO BEING PRESCRIBED ANTICOAGULATION MEDICATION FOR ATRIAL FIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Insufficient Information; Intracranial Hemorrhage

  MAUDE report 23322564 ↗
• InjurySep 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS 28MM TRI-AD HEART BAND, IT WAS EXPLANTED AND REPLACED WITH A 26MM TRI-AD HEART BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23049454 ↗
• InjuryAug 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND, THE PATIENT DEVELOPED NONSUSTAINED VENTRICULAR TACHYCARDIA (NSVT). IT WAS REPORTED THAT AN ANTIARRHYTHMIC MEDICATION WAS GIVEN AND THE EVENT RESOLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tachycardia

  MAUDE report 22715718 ↗
• InjuryAug 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS POST IMPLANT OF THIS TRI-AD HEART BAND, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22685412 ↗
• MalfunctionJul 28, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 4 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT AN ECHOCARDIOGRAM (ECHO) DISCOVERED NO TRICUSPID STENOSIS, A MEAN GRADIENT OF 2MMHG AND MODERATE TRICUSPID REGURGITATION. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22637173 ↗
• InjuryJul 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND AND 28MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT DEVELOPED ATRIAL FIBRILLATION AND ATRIAL FLUTTER. CARDIOVERSION WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter

  MAUDE report 22591255 ↗
• InjuryJul 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS TRI-AD TRICUSPID HEART BAND AND SIMUPLUS MITRAL HEART BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS AV BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22574010 ↗
• InjuryJun 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS TRI-AD RING, THE PATIENT WAS SUFFERING FROM ATRIAL FIBRILLATION (A-FL). THE PATIENT REQUIRED FOUR (4) AMIODARONE BOLUSES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 22307366 ↗
• InjuryJun 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 22187423 ↗
• DeathJun 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT 3 YEARS POST IMPLANT OF THIS 28 MM TRI-AD BAND, THE PATIENT DIED.

  Patient problems: Insufficient Information

  MAUDE report 22182460 ↗
• DeathJun 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AFTER AN UNKNOWN DURATION POST IMPLANT OF THIS 28MM TRI-AD BAND, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE TRI-AD BAND COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 22182356 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22168995 ↗
• InjuryMay 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 1 YEAR AND 5 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND, AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) WAS IMPLANTED DUE TO DILATED CARDIOMYOPATHY AND AN EJECTION FRACTION (EF) OF 25% TO 30%. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 22059483 ↗
• InjuryMay 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND, ELECTROCARDIOGRAM (EKG) PERFORMED ON THE PATIENT NOTED ATRIAL FLUTTER WITH ATRIOVENTRICULAR (AV) BLOCK. IT WAS REPORTED THAT 5 DAYS LATER, ATRIAL FIBRILLATION WAS NOTED ON EKG AND CARDIOVERSION WAS PERFORMED. IT WAS FURTHER REPORTED THAT 1 YEAR AND 8 MONTHS POST IMPLANT, THE PATIENT UNDERWENT CATHETER ABLATION FOR THE ATRIAL FLUTTER AND ATRIAL FIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 22047225 ↗
• InjuryMar 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT DEVELOPED COMPLETE HEART BLOCK WITH JUNCTIONAL RHYTHM CONFIRMED BY ELECTROCARDIOGRAM (ECG). IT WAS STATED THAT A REPEAT ECG THE FOLLOWING DAY DEMONSTRATED THE SAME RESULT ALONG WITH ATRIAL FIBRILLATION ALSO BEING OBSERVED. IT WAS NOTED THAT THE TRANSIENT ATRIAL FIB RILLATION RESOLVED SPONTANEOUSLY. IT WAS MENTIONED THAT THE STANDARD OF CARE ARRHYTHMIC MEDICATION WAS HELD DUE TO COMPLETE HEART BLOCK. IT WAS LATER REPORTED THAT THE 8 DAYS POST IMPLANT OF THE BAND, THE PATIENT DEVELOPED PAROXYSMAL ATRIAL FLUTTER. IT WAS STATED THAT ANOTHER ECG PERFORMED 9 DAYS POST IMPLANT OF THE BAND SHOWED THE PRESENCE OF ATRIAL FLUTTER. IT WAS REPORTED THAT 10 DAYS POSTIMPLANT OF THE BAND, A LEADLESS DUAL-CHAMBER PACEMAKER WAS SUCCESSFULLY IMPLANTED WITH INTRINSIC RHYTHM BEING ATRIAL FLUTTER. IT WAS MENTIONED THAT ARRHYTHMIC MEDICATION WAS THEN INITIATED AFTER PACEMAKER IMPLANT. IT WAS ALSO REPORTED THAT 13 DAYS POST IMPLANT OF THE BAND, DUE TO PERSISTENT ATRIAL FLUTTER, THE PATIENT UNDERWENT A SUCCESSFUL CARDIOVERSION TO SINUS RHYTHM. NO ADDITIONAL ADVERSE PATIENT EFFE

  Patient problems: Atrial Fibrillation; Atrial Flutter; Heart Block

  MAUDE report 21547890 ↗
• InjuryFeb 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND AND 42MM MITRAL ANNULOPLASTY BAND, AN ELECTROCARDIOGRAM (EKG) DISCOVERED ATRIAL TACHYCARDIA WITH A 2 - 1 ATRIOVENTRICULAR (AV) CONDUCTION. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL, AND 1 DAY LATER, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CARDIOVERSION WAS PERFORMED. THE REASON FOR THE INTERVENTION WAS DUE TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21293536 ↗