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SimuPlus™ 7700FR34 (UDI 00763000271411)Recalls & reported problems

Medtronic, Inc. · Ring 7700FR34 SimuPlus Flex 34mm GLB · 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 00763000271411), received between Jun 19, 2023 and Jun 19, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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
  • Insufficient Device Problem Information1

Patient problems

  • Insufficient Information1
  • Mitral Valve Insufficiency/ Regurgitation1

Recent adverse event reports

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

  • InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR REPLACEMENT WAS RESIDUAL MILD MITRAL REGURGITATION POST REPAIR. THE RING WAS REPLACED WITH A MECHANICAL VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

    MAUDE report 17159701 ↗

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.