CG FUTURE® 638BL36 (UDI 00613994758859)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00613994758859), received between Mar 24, 2017 and Jan 17, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2023Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT REPORTED 4 YEARS AND 6 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON-MDT PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED BY THE PATIENT AS, "MY HEART VALVE WAS DEFECTIVE AND THE ANNULOPLASTY BAND NEEDED TO COME OUT BECAUSE IT BURST". IT WAS REPORTED THAT AN ECHOCARDIOGRAM (ECG) PERFORMED 3 DAYS PRIOR TO EXPLANT NOTED THAT THE HEART VALVE WAS ABNORMAL, CONGESTIVE HEART FAILURE (CHF) WITH A PRESERVED EJECTION FRACTION (EF) SEVERE MITRAL REGURGITATION (MR) AND ATRIAL FIBRILLATION. IT WAS ALSO REPORTED THAT UPON GROSS MEDICAL DEVICE EXAMINATION THE VALVE MATERIAL PROSTHETIC HAD SEVERE CALCIFICATION. LASTLY, IT WAS REPORTED THAT THE LEAFLETS WERE ATTACHED TO AN INTACT PLASTIC FRAMEWORK WITH A SUTURE MATERIAL PRESENT INVOLVING THE SEWING RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Heart Failure/Congestive Heart Failure; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16185516 ↗
• InjuryNov 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 11 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND R EPLACED WITH A 32MM 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 15880099 ↗
• InjuryMay 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 8 YEARS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Stenosis

  MAUDE report 11805362 ↗
• InjuryJul 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 35MM MITRAL ANNULOPLASTY BAND OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10277155 ↗
• InjuryJun 4, 2020Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 8 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC PRODUCT. THE RING WAS REPLACED DUE TO DEHISCENCE. THE PHYSICIAN STATED THAT THERE WAS NO MALFUNCTION OF THIS BAND. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10120178 ↗
• InjuryMar 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 34MM ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 9811836 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PERMANENT PACEMAKER IMPLANT WAS REPORTED AS SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 9750333 ↗
• InjuryApr 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 7 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A MITRAL BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Congestive Heart Failure; Mitral Insufficiency; No Information

  MAUDE report 8561681 ↗
• InjuryJan 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS ANNULOPLASTY BAND, THE BAND WAS EXPLANTED FOR UNKNOWN REASONS. IT IS UNKNOWN WHAT THE REPLACEMENT WAS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7203843 ↗
• InjuryDec 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 36 MM ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A 33 MM ANNULOPLASTY BAND DUE TO A SIZING ERROR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; Mitral Valve Prolapse; No Information

  MAUDE report 7112334 ↗
• InjuryMay 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED A DEVICE REGISTRATION FORM FOR THIS DEVICE WITH "IN & OUT" THE ONLY INFORMATION WRITTEN ON THE FORM, INDICATING THAT THE DEVICE WAS IMPLANTED AND EXPLANTED IN THE SAME PROCEDURE. NO PATIENT, FACILITY, OR PHYSICIAN INFORMATION WAS PROVIDED. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6583764 ↗
• InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS ANNULOPLASTY BAND IN THE MITRAL POSITION, IT WAS REPLACED WITH A BIOPROSTHETIC VALVE DUE TO A PERSISTENT LEAK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Insufficiency

  MAUDE report 6432272 ↗