CG FUTURE™ 638BL28Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00643169793590), received between Dec 6, 2018 and Jan 26, 2026 — classified as 1 death, 45 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (32 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Break; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM CG FUTURE HEART BAND, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS A SUTURE BREAKAGE ON THE BUCKLE OF THE FORMING RING HOLDER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24176266 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 6 YEARS AND 3 MONTHS POST IMPLANT OF THIS 28MM 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

  MAUDE report 24176161 ↗
• MalfunctionJan 5, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28 MM CG FUTURE BAND, IT WAS REPLACED WITH ANOTHER MDT PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS A BROKEN SUTURE, IT WAS DISCOVERED THAT THE SUTURE ON THE LOCKING RING OF THE ANNULOPLASTY RING HOLDER HAD BROKEN. THE DOCTOR REPLACED IT WITH A NEW CG ANNULOPLASTY RING AND CONTINUED THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23955186 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MILD REGURGITATION AFTER IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23476830 ↗
• InjuryOct 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 8 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY HEART BAND A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23435595 ↗
• InjurySep 3, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 6 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 22955882 ↗
• InjuryMay 9, 2025Break; Break

  IT WAS REPORTED THAT A CG FUTURE ANNULOPLASTY BAND SUTURE WAS FOUND TO BE BROKEN. THE BROKEN DEVICE WAS REPLACED WITH A NEW BAND OF THE SAME SIZE AND MODEL. IT WAS FURTHER REPORTED THAT THE ANNULOPLASTY BAND WAS NOT FULLY SUTURED PRIOR TO THE SUTURE BREAK. THE PATIENT'S SURGERY WAS NOT AFFECTED, AND THERE WAS NO IMPACT ON THE PATIENT ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995181 ↗
• InjuryMar 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 28MM CG FUTURE MITRAL BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM MOSAIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21718241 ↗
• InjuryFeb 27, 2025Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation; Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation

  IT WAS REPORTED FROM THE PATIENT THAT POST IMPLANT OF THIS MITRAL CG FUTURE ANNULOPLASTY BAND, A TRANSCATHETER VALVE WAS PLACED IN THE MITRAL POSITION. THE REASON FOR REPLACEMENT WAS NOT REPORTED. IT WAS INDICATED THAT THE PATIENT EXPERIENCED MITRAL REGURGITATION AS IT WAS STATED BY THE PATIENT THAT THEIR "HEART WAS BLEEDING PROFUSELY FOLLOWING THE REPAIR" AND HAD TO BE FIXED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemolytic Anemia; Mitral Valve Insufficiency/ Regurgitation; Valvular Insufficiency/ Regurgitation

  MAUDE report 21476502 ↗
• InjuryNov 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM 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 20653712 ↗
• InjuryJun 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ONE WEEK POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS BRADY/TACHY SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 19535420 ↗
• InjuryJun 13, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED BY THE PATIENT THAT AN ECHOCARDIOGRAM (ECHO) DISCOVERED SEVERE MITRAL REGURGITATION (MR). NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19529079 ↗
• InjuryMay 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY AS THE IMPLANT DATE OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED BY THE PATIENT THAT THEY HAD AN ADVERSE REACTION. IT WAS REPORTED BY THE PATIENT THAT THEY WERE "OUT OF THEIR MIND" AFTER SURGERY, AND READMITTED TWO WEEKS LATER. THE PATIENT EXPLAINED THAT THE REACTION WAS "SUPER RARE" AND DID NOT KNOW IF IT WAS RELATED TO THE ANNULOPLASTY PROCEDURE. THEY ALSO REPORTED THAT THEY, "DIED FOR TWO MINUTES IN THE SURGERY AS WELL". IT WAS ALSO NOTED THAT THEY HAD FLUID BUILDUP IN THEIR LUNGS AND BODY. THEY WERE PUT ON CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) AND IN A LOT OF PAIN. A TRIPLE BYPASS SURGERY WAS PERFORMED CONCOMITANTLY DURING THE IMPLANT PROCEDURE. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pleural Effusion

  MAUDE report 19269631 ↗
• InjuryNov 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM 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 18241179 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 9 DAYS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). IT WAS REPORTED THAT THE PATIENT DEVELOPED CARDIOGENIC SHOCK REQUIRING PROLONGED COURSE OF INOTROPES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiogenic Shock; Heart Block

  MAUDE report 16486635 ↗
• InjuryMar 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 34MM RING OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE MITRAL INSUFFICIENCY. NO ADDITIONAL ADVERSEPATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16486126 ↗
• InjuryDec 1, 2022Adverse 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 28MM 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

  MAUDE report 15897464 ↗
• InjuryAug 31, 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 28 MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29 MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS RESIDUAL REGURGITATION. IT WAS STATED THAT THE ANNULOPLASTY BAND DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15326571 ↗
• InjuryAug 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A N ON-MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15241155 ↗
• InjuryJul 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15106843 ↗
• DeathMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DATE OF THE IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE 28MM TRICUSPID ANNULOPLASTY BAND OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 14519455 ↗
• InjuryFeb 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13619591 ↗
• InjuryJan 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 30MM MITRAL ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 13366883 ↗
• InjuryDec 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM 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; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 12975447 ↗
• InjuryDec 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM 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 12969675 ↗