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SimuPlus™ 7700FR36Recalls & reported problems

Medtronic, Inc. · Ring 7700FR36 SimuPlus Flex 36mm 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 00763000271428), received between Apr 11, 2023 and Apr 11, 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

  • Insufficient Device Problem Information1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryApr 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, 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 16718867 ↗

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.