CG FUTURE® 638BL36 (UDI 00613994521095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994521095), received between May 5, 2021 and May 6, 2021 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 11787760 ↗
• InjuryMay 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 6MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM BIOPROSTHETIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11776154 ↗