CG FUTURE™ 638BL30Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00643169793606), received between Jun 26, 2018 and Sep 29, 2026 — classified as 1 death, 62 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (50 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 65 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Insufficient Device Problem Information

  Medtronic received information that 4 days post implant of this 30mm 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 50929527 ↗
• MalfunctionJul 15, 2026Incomplete Coaptation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ANNULOPLASTY HEART BAND DID NOT MALFUNCTION AND IT WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25824960 ↗
• MalfunctionJun 4, 2026Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CG FUTURE ANNULOPLASTY RING/BAND, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S. THE REASON FOR THE REPLACEMENT WAS REPORTED AS COAPTATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25391260 ↗
• InjuryApr 24, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT (B)(6) POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, THE PATIENT IS BEING EVALUATED FOR INT ERVENTION/REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE MITRAL REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24979509 ↗
• InjuryApr 23, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT DURING A MITRAL VALVE REPAIR PROCEDURE, A CG FUTURE 30MM BAND WAS SELECTED FOR IMPLANTATION AFTER VALVE SIZING. FOLLOWING ROUTINE SUTURING, AN INTRAOPERATIVE SALINE (WATER) TEST DETECTED MILD REGURGITATION, AND REFLUX FOLLOWING CG FUTURE IMPLANTATION. IT WAS REPORTED THAT NO ABNORMALITIES WERE NOTED PRIOR TO IMPLANTATION. THE DEVICE WAS EXPLANTED, AND THE PROCEDURE WAS CONVERTED FROM MITRAL VALVE REPAIR TO MITRAL VALVE REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24968266 ↗
• InjuryMar 20, 2026Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE BUCKLE SUTURE ON THE ANNULOPLASTY RING HOLDER WAS BROKEN. THE BROKEN BUCKLE SUTURE AFFECTED THE IMPLANT OF THE ANNULOPLASTY BAND, AND AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, A NEW DEVICE WAS USED INSTEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24654184 ↗
• InjuryJan 19, 2026Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CG FUTURE HEART BAND, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS COAPTATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24107218 ↗
• InjuryDec 12, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CG FUTURE ANNULOPLASTY HEART BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MILD MITRAL REGURGITATION (MR). AFTER SUTURING, A WATER TEST WAS PERFORMED AND MILD REGURGITATION WAS STILL OBSERVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23788751 ↗
• InjurySep 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CG FUTURE HEART 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 23076266 ↗
• InjurySep 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 11 MONTHS POST IMPLANT OF THIS 30MM 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 23067448 ↗
• InjuryJun 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 2 YEARS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS VALVE PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22195076 ↗
• InjuryMay 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CG FUTURE BAND, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS DUE TO A BROKEN BUCKLE SUTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22086027 ↗
• InjuryFeb 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS CG FUTURE 30MM ANNULOPLASTY BAND HAD A POOR FORMING EFFECT. IT WAS FURTHER STATED THAT THE BAND HAD POOR SHAPE AFTER FORMING. THE PRODUCT WAS SUBSEQUENTLY EXPLANTED AND REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. IT WAS STATED THAT THE DEVICE DID NOT MALFUNCTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21324506 ↗
• InjuryJan 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PROCEDURE, A HEART BAND WAS "WASTED" AND REPLACED WITH A HEART BAND OF THE SAME MODEL AND SIZE WHICH WAS SUBSEQUENTLY IMPLANTED IN THE MITRAL POSITION ON (B)(6) 2024. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21067762 ↗
• InjuryOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 9 MONTHS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 26MM 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 20429209 ↗
• InjuryOct 1, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS REPLACED WITH A BAND OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS WHILE SUTURING ON THE BAND, IT WAS OBSERVED THAT THE BUCKLE SUTURE ON THE BAND FIXATOR WAS BROKEN. IT WAS MENTIONED THAT THE DEVICE WAS INSPECTED PRIOR TO USE UPON ITS REMOVAL FROM ITS PACKAGING AND NO ISSUES WERE NOTED AT THAT TIME. IT WAS REPORTED THAT THE CINCH WAS NOT OVERTIGHTENED WHILE PREPARING THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20342427 ↗
• InjurySep 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 12 DAYS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT THEY HAD AN INFECTION WHICH REQUIRED HOSPITALIZATION. IT WAS STATED THAT THEY WERE HOSPITALIZED FOR 4 DAYS AND RECEIVED INTRAVENOUS (IV) FLUIDS. IT WAS ALSO REPORTED THAT THE PATIENT HAD PERICARDITIS AND SEPSIS. THE PATIENT ALSO NOTED THAT THEIR "LEFT FEMORAL ARTERY WAS INFECTED FROM THE LINE FROM SURGERY" AND THAT THEY HAD "A BLOOD CLOT AND THE AREA IS SWOLLEN". SUBSEQUENTLY, 28 DAYS LATER, THE PATIENT HAD NORMAL LABS AND BLOOD COUNTS, AS A COMPUTED TOMOGRAPHY (CT) SCAN AND ELECTROCARDIOGRAM (EKG) DEMONSTRATED NO FURTHER ISSUES. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Inflammation; Sepsis; Thrombosis/Thrombus

  MAUDE report 20234655 ↗
• InjuryJul 22, 2024Adverse 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 ADDITIONAL INFORMATION THAT REPORTED THE REASON FOR REPLACEMENT AS SYSTOLIC ANTERIOR MOTION (SAM). THE REPLACEMENT DEVICE WAS A 29MM MITRAL BIOPROSTHETIC VALVE. IT WAS ALSO REPORTED THAT THE PATIENT HAD ANATOMICAL FACTORS SUCH AS A LARGE CLEFT ON THE ANTERIOR LEAFLET WHICH CONTRIBUTED TO THE EVENT. IT WAS REPORTED THAT THE 30MM MITRAL ANNULOPLASTY BAND DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19794799 ↗
• InjuryJul 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM 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 19721373 ↗
• InjuryJun 20, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 MONTH POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY BAND, A 29MM NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-BAND. THE REASON FOR THE INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19578520 ↗
• InjuryFeb 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM 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 18763763 ↗
• InjuryJan 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM 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 18518211 ↗
• InjuryOct 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM 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 17927419 ↗
• InjuryAug 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM 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 17538864 ↗
• InjuryNov 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM AORTIC ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 25MM AORTIC MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15804892 ↗