CG FUTURE™ 638RL30Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00643169793538), received between May 25, 2018 and Jun 29, 2026 — classified as 1 death, 43 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (26 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.

• InjuryJun 29, 2026Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CG FUTURE MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 32MM CG FUTURE ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MILD REGURGITATION CAUSED BY THE ANNULOPLASTY RING. IT WAS FURTHER NOTED THAT THE PATIENT'S ANNULUS MEASURED BETWEEN 31MM AND 33MM. AFTER SUTURING AND IMPLANT OF THE 32MM ANNULOPLASTY BAND, MILD REGURGITATION AND SYSTOLIC ANTERIOR MOTION (SAM) OCCURRED. THE 32MM ANNULOPLASTY BAND WAS EXPLANTED AND REPLACED WITH A VALVE PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 25651702 ↗
• InjuryApr 3, 2026Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AFTER SUTURING, A SALINE TEST WAS PERFORMED AND REVEALED A SMALL AMOUNT OF MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24774908 ↗
• InjuryApr 1, 2026Structural Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CG FUTURE ANNULOPLASTY HEART RING, IT WAS EXPLANTED AND REPLACED WITH A 24MM OPEN PIVOT MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE MITRAL REGURGITATION (MR) AND THE REMODELING EFFECT WAS POOR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24757073 ↗
• InjuryFeb 12, 2026Patient Device Interaction Problem; Thickening of Material

  IT WAS REPORTED THAT IN FEBRUARY 2025, POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, THE PATIENT EXPERIENCED A SECOND STROKE. IT WAS REPORTED THAT THERE WAS NO INDICATION THAT THE EVENT WAS DEVICE RELATED AND A CARDIAC MONITORING DEVICE (LINQ) WAS IMPLANTEDTO DETERMINE THE SOURCE OF THE EVENT. IT WAS FURTHER STATED THAT THE PHYSICIAN BELIEVES THAT THE STROKES WERE LIKELY DUE TO GRANULOMA ON THE SUTURES AND THE RING. IT WAS ALSO STATED THAT THE RING WAS SMALL IN SIZE WHICH HAD MOST LIKELY RESTRICTED FLOW AND PANNUS GROWTH WAS OBSERVED WHICH WAS EXCESSIVE. IT WAS ALSO REPORTED THAT MOST OF THE P1 (LEAFLET) APPEARED TETHERED, P2 AND P3 WERE RESTRICTED AND THERE WERE MULTIPLE MOBILE GRANULOMAS ON THE COREKNOT. IT WAS REPORTED THAT THE PATIENT'S CEREBROVASCULAR ACCIDENT (CVA) OR STROKE WAS SUCCESSFULLY TREATED WITH THROMBOLYTIC MEDICATION AND A THROMBECTOMY, AND THE PATIENT RECOVERED WITHOUT ADDITIONAL COMPLICATIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Corneal Pannus; Granuloma; Loss of Vision; Stroke/CVA

  MAUDE report 24321300 ↗
• InjuryFeb 11, 2026Thickening of Material; Device Stenosis

  IT WAS REPORTED THAT 3 YEARS AND 11 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A MECHANICAL MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Corneal Pannus; Granuloma; Mitral Valve Stenosis

  MAUDE report 24313853 ↗
• InjuryJan 26, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CG FUTURE HEART RING, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S 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 24176445 ↗
• InjuryJan 26, 2026Break; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CG FUTURE HEART RING, 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. THE SUTURE BROKE WHILE WIRING THE CG FUTURE FORMING RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24176239 ↗
• InjuryJan 16, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS RESIDUAL REGURGITATION. IT WAS REPORTED THAT THE ANNULOPLASTY PRODUCT WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. IT WAS STATED THAT THE ANNULOPLASTY PRODUCT DID NOT MALFUNCTION AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24092249 ↗
• MalfunctionDec 2, 2025Structural Problem; Intravalvular regurgitation; Structural Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CG FUTURE HEART RING, IT WAS REPLACED WITH A COMPETITOR'S MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED DUE TO POOR FORMING OF THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23690841 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Intravalvular regurgitation; Adverse Event Without Identified Device or Use Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. 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 23629602 ↗
• InjuryNov 6, 2025Patient Device Interaction Problem; Material Split, Cut or Torn; Patient Device Interaction Problem; Material Split, Cut or Torn

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

  Patient problems: Insufficient Information

  MAUDE report 23486953 ↗
• 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 30MM MITRAL ANNULOPLASTY RING, 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 23066743 ↗
• InjuryAug 28, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS WHEN WATER TESTING THE VALVE, A SMALL AMOUNT OF REGURGITATION WAS PRESENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22916067 ↗
• InjuryAug 27, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS POST IMPLANT OF THIS 30MM CG FUTURE MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM MECHANICAL 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 22902264 ↗
• InjuryJul 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 30MM CG FUTURE BAND IN THE MITRAL POSITION, IT WAS EXPLANTED AND REPLACED WITH A 25MM MOSAIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22492161 ↗
• InjuryJun 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 30MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22317812 ↗
• InjuryJun 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A N UNKNOWN PRODUCT THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22299127 ↗
• MalfunctionFeb 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHEN PREPARING TO USE THE 30MM ANNULOPLASTY RING ON THE PATIENT, THE VALVE RING WAS FOUND TO BE DAMAGED. IT WAS REPLACED WITH A INTACT VALVE RING.

  Patient problems: Insufficient Information

  MAUDE report 21362638 ↗
• MalfunctionAug 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS 30MM ANNULOPLASTY RING, IT WAS REPORTED THAT USE OF THE DEVICE WAS ABNORMAL. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071514 ↗
• InjuryApr 4, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 11 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL REGURGITATION DUE TO ANATOMY. IT WAS STATED THAT THE RING PERFORMED AS INTENDED AND IT WAS STRICTLY A PATIENT ANATOMICAL ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19039759 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 4 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, THE PATIENT HAD AN ISCHEMIC STROKE. A TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) WAS PERFORMED AND POSSIBLE VEGETATION WAS OBSERVED ON THE LEAFLET OF THE MITRAL VALVE, HOWEVER, NO VEGETATION WAS OBSERVED ON THE RING. BLOOD CULTURES PERFORMED CAME UP NEGATIVE. A THROMBUS OR VEGETATION WAS UNABLE TO BE RULED OUT. ANTICOAGULANT AND INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. THE PATIENT WAS DISCHARGED 5 DAYS LATER WITH HOME CARE/HOME INFUSION AND THERAPIES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 17381138 ↗
• DeathMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT AFTER AN UNKNOWN DURATION POST IMPLANT OF THIS 30MM ANNULOPLASTY RING, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE PRODUCT OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 16485698 ↗
• InjuryOct 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS 30 MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33 MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15544482 ↗
• InjuryAug 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. 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 15201988 ↗
• InjuryFeb 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, 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 13441700 ↗