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CG FUTURE® 638BL34 (UDI 00613994521101)Recalls & reported problems

Medtronic, Inc. · BAND 638BL34 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 00613994521101), received between Jan 17, 2019 and Jan 17, 2019 — 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

  • No Information1

Recent adverse event reports

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

  • InjuryJan 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY EIGHT YEARS AND ONE MONTH POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTSWERE REPORTED.

    Patient problems: No Information

    MAUDE report 8258511 ↗

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.