Tri-Ad™ 900SFC34Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169195387), received between Mar 18, 2019 and Jul 17, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 34MM ANNULOPLASTY RING, 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 22530808 ↗
• InjuryFeb 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 7 MONTHS POST IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE PLACED IN THE TRICUSPID LOCATION. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. CONCOMITANTLY, BY THE SAME IMPLANTING PHYSICIAN, A PERMANENT PACEMAKER AND 2 LEADS WERE IMPLANTED, THE REASON GIVEN FOR THE PERMANENT PACEMAKER IMPLANT WAS "VALVE DISEASE". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18715219 ↗
• InjuryMay 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THAT THE MECHANISM OF SEVERE MITRAL REGURGITATION WAS ANNULUS DILATATION AND TETHERING OF THE POSTERIOR LEAFLET. THE PHYSICIAN/AUTHOR ADDED THAT IT WAS NOT POSSIBLE TO ATTRIBUTE THE CAUSALITY OF THE MITRAL REGURGITATION TO THE TRI-AD RING. THE TRICUSPID RING REMAINED IN THE PATIENT. THE PATIENT'S WEIGHT WAS 72 KG.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16946499 ↗
• InjuryMar 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8428583 ↗