CG FUTURE™ 638BL38Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00643169793644), received between Sep 30, 2019 and Sep 30, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient Device Interaction Problem

  Medtronic received information that 1 month post implant of this 34mm tricuspid band and this 38mm mitral annuloplasty band, a Bi-Ventricular defibrillator was implanted. The reason for the Bi-Ventricular defibrillator was reported as low ejection fraction (EF). No additional adverse patient effects were reported.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50943042 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 11 MONTHS POST IMPLANT OF THIS 38 MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 30 MM MITRAL ANNULOPLASTY BAND OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25677748 ↗
• InjuryMay 19, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE 38MM MITRAL ANNULOPLASTY BAND, THE SHAPING RESULT AFTER IMPLANTATION WAS SUBOPTIMAL AND THE NATIVE VALVE LEAFLET COAPTATION OUTCOME WAS UNSATISFACTORY. THE DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER MANUFACTURER¿SPRODUCT. IT WAS FURTHER NOTED THAT THE ANNULOPLASTY BAND DID NOT MALFUNCTION, AND WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. IT WAS STATED THAT THE LEAFLET COAPTATION ISSUES WAS NOT DUE TO THE PATIENT ANATOMY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 25221678 ↗
• InjuryApr 3, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT HAVE ANY PRE-EXISTING ARRHYTHMIAS PRIOR TO THE HEART VALVE IMPLANT AND THE PHYSICIAN BELIEVES THE HEART VALVE OR IMPLANT PROCEDURE CAUSED OR CONTRIBUTED TO THE CONDUCTION DISTURBANCE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 24776366 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF  THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24764904 ↗
• MalfunctionMar 4, 2026Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO IMPLANTING THIS 38MM CG FUTURE ANNULOPLASTY DEVICE, THE ANNULOPLASTY RING FRACTURED, AFFECTING NORMAL USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24512061 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS RECURRENT SEVERE MITRAL REGURGITATION. IT WAS ALSO REPORTED THAT THE MITRAL REGURGITATION WAS NOT RELATED TO THE ANNULOPLASTY RING, AND MAY HAVE BEEN RELATED TO A PATCH ON THE A2 PORTION OF THEIR ANTERIOR LEAFLET. THE PATIENT ALSO HAD A PREVIOUS ENDOCARDITIS INFECTION, AND THE ORGANISM CULTURED WAS UNKNOWN. IT WAS FURTHER REPORTED THAT THE RING WAS INTACT AND NOT DEHISCED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24114647 ↗
• InjuryMar 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM BAND OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21574551 ↗
• InjuryMar 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. THE IMPLANT FORM STATED, "EXPLANTED/WASTED". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18960521 ↗
• InjuryFeb 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 38MM BAND OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18713117 ↗
• InjuryFeb 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, 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 18667518 ↗
• InjuryNov 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, 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 18123472 ↗
• InjuryOct 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, 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 17959790 ↗
• InjuryNov 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A BAND OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15722278 ↗
• InjuryOct 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 5 MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 36MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15572423 ↗
• InjuryMay 9, 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 38 MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33 MM NON-MEDTRONIC BIOPROSTHETIC VALVE. IT WAS REPORTED THE ANNULOPLASTY BAND WAS SUTURED IN PLACE AND SECURED WITH COR-KNOTS DUE TO CALCIFICATION OF THE POSTERIOR VALVE AND ANNULUS. THE VALVE WAS TESTED AND FOUND TO BE COMPETENT, HOWEVER, "THERE WAS 1 AREA OF PROLAPSING A3 AND A LATERAL COMMISSUROPLASTY WAS PERFORMED IN ORDER TO PLACE THIS LEAFLET IN A NORMAL PLANE WITH THE MITRAL VALVE." TEMPORARY WEANING FROM CARDIOPULMONARY BYPASS (CPB) WAS SUCCESSFUL, HOWEVER, "THE PATIENT HAD SIGNIFICANT SYSTOLIC ANTERIOR MOTION OF THE MITRAL VALVE THAT WAS ALSO CAUSE A JET OF REGURGITATION, IN ADDITION TO A 60 TO 100 MMHG GRADIENT ACROSS THE OUTFLOW TRACT." THEREFORE, THE PATIENT WAS PUT BACK ON BYPASS AND THE 38 MM ANNULOPLASTY BAND WAS REMOVED AND REPLACED WITH THE 33 MM NON-MEDTRONIC BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 14337617 ↗
• InjuryApr 6, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM AORTIC ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 34MM ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14023272 ↗
• InjurySep 23, 2021Adverse 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 DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12519156 ↗
• InjuryDec 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 10935113 ↗
• InjuryMay 20, 2020Adverse 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 A 38MM ANNULOPLASTY HEART BAND WAS IMPLANTED IN THE MITRAL POSITION AND EXPLANTED ON THE-SAME DAY. IT WAS ALSO REPORTED THAT AFTER THE EXPLANT, A 33MM BIOPROSTHETIC VALVE WAS IMPLANTED IN THE MITRAL POSITION. REASON FOR EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 10076764 ↗
• InjurySep 30, 2019Adverse 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 THIS 38MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9134799 ↗