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Simulus™ 700FF23Recalls & reported problems

Medtronic, Inc. · RING SIM 700FF23 FULLY FLEXIBLE · 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 00643169182325), received between Jan 2, 2019 and Jan 2, 2019 — 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

  • Tricuspid Insufficiency1

Recent adverse event reports

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

  • InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY AFTER IMPLANTING THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE DUE TO SIGNIFICANT RESIDUAL INSUFFICIENCY. THE SURGEON INDICATED THERE WAS NO PROBLEM WITH THE PRODUCT AND THAT A VALVE REPAIR WAS NOT ADEQUATE FOR THIS PATIENT, SO A VALVE REPLACEMENT WAS ELECTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Tricuspid Insufficiency

    MAUDE report 8208394 ↗

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.