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CG FUTURE® 638BL28 (UDI 00613994521132)Recalls & reported problems

Medtronic, Inc. · BAND 638BL28 CG FUTURE 10L · Class 2

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 00613994521132), received between Mar 2, 2020 and Mar 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Reflux within Device” (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

  • Reflux within Device1

Patient problems

  • Tricuspid Regurgitation1

Recent adverse event reports

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

  • InjuryMar 2, 2020Reflux within Device; Reflux within Device

    MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 6 MONTHS POST IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY RING AND 28MM MITRAL ANNULOPLASTY BAND IN THE TRICUSPID POSITION, THE MITRAL RING WAS EXPLANTED AND REPLACED WITH A 25MM NON-MEDTRONIC VALVE DUE TO MITRAL STENOSIS. THE 28MM ANNULOPLASTY BAND WAS REPAIRED DUE TO INCREASED TRICUSPID REGURGITATION BY SEWING A 28MM TRICUSPID ANNULOPLASTY BAND OF A DIFFERENT MODEL OVER IT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Tricuspid Regurgitation

    MAUDE report 9774917 ↗

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.