Tri-AdRecalls & reported problems across all models

We found 12 models of Tri-Ad by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 145 adverse event reports in the FDA's MAUDE database, received between Jan 9, 2017 and Sep 30, 2026 — classified as 7 deaths, 137 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (63 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Tri-Ad problems

Tri-Ad models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tri-Ad™ 900SFC228

  RING, ANNULOPLASTY
  4 deaths56 reports
• Tri-Ad™ 900SFC28

  RING, ANNULOPLASTY
  15 reports
• Tri-Ad™ 900SFC230

  RING, ANNULOPLASTY
  14 reports
• Tri-Ad™ 900SFC232

  RING, ANNULOPLASTY
  2 deaths14 reports
• Tri-Ad™ 900SFC226

  RING, ANNULOPLASTY
  1 death11 reports
• Tri-Ad™ 900SFC32

  RING, ANNULOPLASTY
  10 reports
• Tri-Ad™ 900SFC26

  RING, ANNULOPLASTY
  6 reports
• Tri-Ad™ 900SFC30

  RING, ANNULOPLASTY
  6 reports
• Tri-Ad™ 900SFC234

  RING, ANNULOPLASTY
  5 reports
• Tri-Ad™ 900SFC34

  RING, ANNULOPLASTY
  4 reports
• Tri-Ad™ 900SFC236

  RING, ANNULOPLASTY
  3 reports
• Tri-Ad™ 900SFC36

  RING, ANNULOPLASTY
  1 report

Recent Tri-Ad adverse event reports

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

• InjurySep 30, 2026Patient Device Interaction Problem

  Medtronic received information that 1 month post implant of this 34mm tricuspid band and this 38mm mitral annuloplasty band, a Bi-Ventricular defibrillator was implanted. The reason for the Bi-Ventricular defibrillator was reported as low ejection fraction (EF). No additional adverse patient effects were reported.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50943046 ↗
• InjuryJul 29, 2026Patient Device Interaction Problem

  It was reported that 7 days post implant of this 30mm tricuspid annuloplasty band, a permanent pacemaker was implanted. The reason for the permanent pacemaker was reported as sick sinus syndrome (SSS) and atrial arrythmias (atrial tachycardia (AT), atrial fibrillation (AF) and atrial flutter (A-Fl). No additional adverse patient effects were reported.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Tachycardia

  MAUDE report 50065971 ↗
• 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 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 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AN REPLACED WITH A 33MM MITRAL BI OPROSTHETIC VALVE IN THE TRICUSPID POSITION. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24637381 ↗
• 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 ↗
• 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 ↗
• InjuryMar 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 DAYS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, AN ELECTROCARDIOGRAM (EKG) SHOWED ATRIAL FIBRILLA TION. IT WAS REPORTED THAT 5 DAYS LATER, ON (B)(6) 2025, THE PATIENT UNDERWENT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND CARDIOVERSION AND CONVERTED TO NORMAL SINUS RHYTHM WITH 1ST DEGREE BLOCK. IT WAS ALSO REPORTED THAT THE PATIENT WAS TEMPORARILY RECEIVING ANTIARRHYTHMIC MEDICATIONS. IT WAS FURTHER NOTED THAT THE PATIENT WAS DISCHARGED WITH A HOME CARDIAC EVENT MONITOR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 24519926 ↗
• InjuryMar 4, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 DAYS POST IMPLANT OF THIS OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, AN ELECTROCARDIOGRAM SHOWED THAT THE PATIENT DEVELOPED COMPLETE HEART BLOCK (CHB). SUBSEQUENTLY IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT SUCCESSFULLY HAD A DUAL CHAMBER LEADLESS PERMANENT PACEMAKER IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 24512181 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED IN THE SAME POSITION WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24176809 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PROD UCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24078088 ↗
• 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 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 7 DAYS POST IMPLANT OF THIS 34MM ANNULOPLASTY BAND AND 21 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS REPORTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS LOW EJECTION FRACTION (EF). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23775981 ↗

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