CG FUTURE® 638BL34 (UDI 00613994758835)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00613994758835), received between May 9, 2017 and May 26, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 reports).

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 6 MONTHS POST IMPLANT OF THIS 34MM CG FUTURE MITRAL BAND, IT WAS EXPLANTED AND REPLACED WITH A UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS "TOO MUCH PLAQUE ON THE MITRAL VALVE". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22083333 ↗
• InjuryJan 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 8 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21072136 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE MITRAL REGURGITATION. IT WAS REPORTED THAT THE 34MM MITRAL ANNULOPLASTY BAND DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15404878 ↗
• InjuryAug 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 1 MONTH POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM ANNULOPLASTY BAND OF A DIFFERENT MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS MODERATE TO SEVERE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 8890660 ↗
• InjuryJul 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS 9 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Dyspnea; Mitral Regurgitation; Mitral Valve Stenosis; No Information

  MAUDE report 8841402 ↗
• InjuryJul 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 9 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND THE PATIENT'S VALVE WAS REPLACED WITH A NON-MEDTRONIC MECHANICAL VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8798745 ↗
• InjuryApr 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM A PATIENT THAT THREE YEARS AND EIGHT MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 23MM BAND OF A DIFFERENT MODEL DUE TO "COMPLICATIONS". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8527292 ↗
• InjuryOct 26, 2018Adverse 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 INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8009558 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY BAND, TESTING REVEALED RESIDUAL REGURGITATION. THE BAND WAS EXPLANTED AND REPLACED WITH A 31MM NON-MEDTRONIC BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7976075 ↗
• InjuryAug 22, 2018Adverse 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 INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 7805212 ↗
• InjuryNov 28, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE PATIENT HAD A SAM (SYSTOLIC ANTERIOR MOTION) WHICH WAS UNRELATED TO THE DEVICE SO THE PHYSICIAN CHOSE TO REMOVE THE DEVICE AND IMPLANT A LARGER SIZE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 7063139 ↗
• InjuryNov 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7041205 ↗
• InjuryNov 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE AS THE PHYSICIAN STATED THAT THE REPAIR OF THE PATIENTS NATIVE VALVE WAS NOT COMPETENT. A BIOPROSTHETIC HEART VALVE WAS IMPLANTED IN ITS PLACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7029199 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A NON-MED TRONIC BIOPROSTHETIC VALVE. THE PHYSICIAN REPORTED THERE WAS NO ALLEGATION AGAINST THE RING, BUT THE REPAIR WITH THE RING WAS JUDGED NOT ADEQUATE FOR THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 7013603 ↗
• InjurySep 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 34MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED ON THE SAME DAY FOR UNKNOWN REASONS. THE DEVICE WAS REPLACED WITH A 32MM ANNULOPLASTY BAND. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6856867 ↗
• InjuryMay 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS 34 MM ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29 MM BIOPROSTHETIC VALVE. NO FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6553346 ↗