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Tri-Ad™ 900SFC36Recalls & reported problems

Medtronic, Inc. · RING 900SFC36 TRI-AD ADAMS · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169195394), received between Jan 23, 2018 and Jan 23, 2018 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN NON-MEDTRONIC MITRAL VALVE. THE PHYSICIAN REPORTED THE RING DID NOT CORRECT THE VALVE INCOMPETENCE. THE PATIENT STATUS IMMEDIATELY FOLLOWING THE IMPLANT OF THE NON-MEDTRONIC PRODUCT WAS NOT REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7212409 ↗

Other RING, ANNULOPLASTY devices

All RING, ANNULOPLASTY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.