CG FUTURE™ 638BL32Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00643169793613), received between May 4, 2018 and Aug 23, 2026 — classified as 1 death, 64 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (38 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 71 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2026Intravalvular regurgitation

  Medtronic received information that during the implant of this 32mm mitral annuloplasty band, it was explanted and replaced with a 29mm mitral bioprosthetic valve. The reason for the replacement was reported as during the patients mitral valve replacement patient's native posterior and anterior leaflet prolapse was addressed and the band was used to repair the patients mitral valve. It was reported after the repair an intraoperative transesophageal echocardiogram (TEE) showed a residual leak of 1.5 - 2+, and the physician determined that repair was not adequate, therefore the annuloplasty band was explanted and a 29mm mitral bioprosthetic valve was implanted. It was further reported post implant the transesophageal echocardiogram (TEE) showed no obvious paravalvular leak, and the mitral valve was functioning appropriately with no gradient across the mitral valve. It was further noted that the patient was discharged on (b)(6) 2026. No additional adverse patient effects were reported.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50397246 ↗
• MalfunctionJun 8, 2026Device Markings/Labelling Problem

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION OF USE OF THIS 32MM ANNULOPLASTY BAND, IT WAS REPORTED THAT WHEN THE BARCODE ON THE PRODUCT PACKAGING WAS SCANNED BY THE HEALTHCARE PROFESSIONAL (HCP), AND THE DEVICE WAS CATEGORIZED AS A 34MM ANNULOPLASTY BAND IN THE HOSPITAL SYSTEM. THE 34MM SIZE DID NOT MATCH THE LABELED 32MM SIZE OF THE DEVICE. IT IS UNKNOWN IF A PATIENT WAS INVOLVED IN THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 25428430 ↗
• InjuryApr 27, 2026Structural Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM CG FUTURE ANNULOPLASTY HEART BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED DUE TO THE LEFT AND RIGHT SIDES OF THIS MITRAL ANNULOPLASTY RING HAVING DIFFERENT HEIGHTS, WITH A RELATIVELY LARGE DEVIATION, WHICH AFFECTED THE POSTOPERATIVE OUTCOME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24997615 ↗
• InjuryMar 20, 2026Inadequacy of Device Shape and/or Size; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 34MM ANNULOPLASTY RING. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AFTER IMPLANT, MODERATE TO SEVERE MITRAL REGURGITATION WAS DETECTED. IT WAS FURTHER REPORTED THAT THE REGURGITATION WAS DUE TO SIZE MISMATCH OR PATIENT PROTHESIS MISMATCH. THE ANNULUS WAS RESIZED, AND A 34MM ANNULOPLASTY RING WAS IMPLANTED. THERE WAS NO REGURGITATION POST IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24654463 ↗
• InjuryMar 20, 2026Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INNER AND OUTER PACKAGING OF THE ANNULOPLASTY BAND WAS INTACT. THE DEVICE WAS NOT FULLY SUTURED AND TESTED PRIOR TO REMOVAL DUE TO THE SUTURE BREAKAGE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24653111 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1 YEARS AND 11 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 34MM 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 24574628 ↗
• InjuryFeb 5, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT POST REPAIR USING THIS 32MM ANNULOPLASTY BAND, THE BAND WAS TESTED AND APPEARED HYDROSTATIC. IT WAS REPORTED THAT MITRAL REGURGITATION WAS PRESENT POST REPAIR. THE SURGEON WAS UNHAPPY WITH THE REPAIR AND A DECISION WAS MADE TO EXPLANT THE 32MM ANNULOPLASTY BAND. THE 32MM ANNULOPLASTY BAND WAS EXPLANTED AND REPLACED WITH A 31MM MOSAIC BIOPROSTHETIC VALVE. IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THE 31MM MOSAIC BIOPROSTHETIC VALVE, IT WAS NOTED THAT THE ANTEROLATERAL ANTERIOR NATIVE VALVE LEAFLET WAS MODERATELY CALCIFIED AT THE HINGE POINT WHICH MAY HAVE CONTRIBUTED TO THE MITRAL REGURGITATION FOLLOWING REPAIR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24269420 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 32MM 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 24177208 ↗
• InjuryJan 26, 2026Break; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM 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 DUE TO THE SUTURE ON THE BUCKLE OF THE CG FUTURE ANNULOPLASTY RING'S FIXATION DEVICE HAD BROKEN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24176428 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 30MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS WASTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23987766 ↗
• InjuryDec 30, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE ANNULOPLASTY BAND WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23924410 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR INTERVENTION AS RESIDUAL REGURGITATION. THE DEVICE DID NOT MALFUNCTION AND THE DEVICE WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23826046 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT 2 YEARS AND 4 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY HEART 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 23642490 ↗
• InjurySep 16, 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 32MMMM 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 23067670 ↗
• InjurySep 2, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM CG FUTURE HEART BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MILD REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22937802 ↗
• InjuryAug 6, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A MITRAL VALVE REPAIR OPERATION, AFTER OPENING THE CHEST, THE PATIENT'S LEFT AND RIGHT FIBROUS TRIANGLE DISTANCES AND ANTERIOR LEAFLET AREA WERE MEASURED. IT WAS REPORTED THAT A 32MM MITRAL ANNULOPLASTY RING WAS SELECTED AND DURING THE IMPLANT, IT WAS "DISCOVERED THAT THE FABRIC WRAPPING AROUND THE ANNULI HAD BECOME LOOSED, EXPOSING THE METAL" AND THERE WERE HOLES IN THE FABRIC WRAPPED AROUND THE RING. IT WAS STATED THAT THE SURGEON REPLACED THE RING AND CONTINUED THE OPERATION WITHOUT AFFECTING THE PATIENT. THE ANNULOPLASTY PRODUCT WAS NOT FULLY SUTURED AND TESTED PRIOR TO REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 22731508 ↗
• InjuryJul 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS POST IMPLANT OF THIS 32MM CG FUTURE BAND, IT WAS EXPLANTED AND REPLACED WITH A TRI-AD DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22675906 ↗
• InjuryJul 9, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32 MM CG FUTURE BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MODERATE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22457198 ↗
• InjuryJun 27, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT THIS 32MM ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. 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 22346628 ↗
• MalfunctionDec 5, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, THE PATIENT WAS REPORTED TO BE EXPERIENCING MITRAL REGURGITATION. IT WAS STATED THAT THE REGURGITATION IS RELATED TO THE PATIENTS HYPERTENSION; THE PATIENT HYPERTENSION THERAPY WAS CHANGED. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20853882 ↗
• InjuryNov 25, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT DURING A MITRAL VALVULOPLASTY PROCEDURE, A CG FUTURE BAND WAS IMPLANTED, AND REGURGITATION WAS OBSERVED DURING THE WATER INJECTION TEST. THE SURGICAL EFFECT WAS NOT IDEAL AND THE DEVICE WAS EXPLANTED AS A RESULT. IT WAS REPLACED WITH AN UNKNOWN PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20769875 ↗
• MalfunctionNov 7, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS NOT IMPLANTED, IT WAS REPLACED WITH AN ANNULOPLASTY BAND OF THE SAME MAKE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE SUTURE CONNECTING THE BAND TO THE SUPPORT HOLDER WAS BROKEN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632352 ↗
• MalfunctionNov 7, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE FOR THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS REPLACED WITH A BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE SUTURE CONNECTING THE BAND TO THE HOLDER BROKE DURING THE WIRING PROCESS. IT WAS STATED THAT THE ANNULOPLASTY PRODUCT WAS NOT FULLY SUTURED AND TESTED PRIOR TO REMOVAL. IT WAS STATED THAT THE ANNULOPLASTY PRODUCT HAD BEEN INSPECTED UPON REMOVAL FROM THE PACKAGING WITH NO ISSUES NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632286 ↗
• InjuryOct 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY BAND, IT WAS REPLACED WITH AN UNKNOWN PRODUCT. IT WAS FURTHER NOTED THAT THE DEVICE WAS USED BUT NOT IMPLANTED. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20471440 ↗
• InjuryOct 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 1 MONTH POST IMPLANT OF THIS 32 MM MITRAL ANNULOPLASTY BAND, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI). NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Myocardial Infarction

  MAUDE report 20461668 ↗