Tri-Ad™ 900SFC234Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000102340), received between Aug 31, 2023 and Sep 30, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 5 most recent of 5 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryAug 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM 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 20075757 ↗
• InjuryAug 31, 2023Adverse 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 34MM TRICUSPID ANNULOPLASTY BAND, ATRIAL FLUTTER WITH VARIABLE ATRIO -VENTRICULAR BLOCK WAS OBSERVED ON A ELECTROCARDIOGRAM. NO INTRACARDIAC THROMBUS WAS OBSERVED. CARDIOVERSION WAS PERFORMED 1 DAY FOLLOWING THIS OBSERVATION. 3 DAYS FOLLOWING TREATMENT, AN ELECTROCARDIOGRAM REVEALED ONGOING ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSES. IT WAS STATED THAT THE ATRIAL FIBRILLATION AND ATRIAL FLUTTER WAS RELATED TO THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17664183 ↗