CG FUTURE™ 638RL34Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00643169793552), received between Jul 25, 2018 and May 4, 2026 — classified as 1 death, 26 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE LEVEL OF REGURGITATION AS MODERATE AND IT WAS CONFIRMED THE ANNULOPLASTY PRODUCT WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. THE DEVICE DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 25070378 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, 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 24856967 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR THE REPLACEMENT WAS MODERATE REGURGITATION. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24755392 ↗
• InjuryMar 6, 2026Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM CG FUTURE MITRAL ANNULOPLASTY HEART RING, IT WAS EXPLANTED AND REPLACED WITH A 34MM MITRAL ANNULOPLASTY RING FROM ANOTHER MANUFACTURER. THE REASON FOR THE REPLACEMENT WAS REPORTED THAT AFTER IMPLANTATION, PERSISTENT REGURGITATION WAS OBSERVED THROUGH REPEATED INTRAOPERATIVE TESTING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24532431 ↗
• InjuryDec 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT THE SAME DAY POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT THEIR LUNG COLLAPSED AND THEY HAD PHRENIC NERVE DAMAGE. NO INTERVENTION OR TREATMENT HAS BEEN PERFORMED. IT WAS ALSO NOTED THAT AN UNKNOWN DURATION POST IMPLANT, THE PATIENT HAS BEEN EXPERIENCING REDNESS ON THEIR CHEST, AND HIVES ON THEIR BACK AND LEFT ARM. THE PATIENT TAKES BENADRYL TO HELP WITH THESE SYMPTOMS. IT WAS ALSO SHARED THAT THE PATIENT HAS FOOD ALLERGIES, THEREFOR THEY WILL FOLLOW-UP WITH THEIR ALLERGIST TO DETERMINE ANY NEW ALLERGIES. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Local Reaction; Nerve Damage; Pneumothorax

  MAUDE report 23751480 ↗
• DeathJul 9, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT POST IMPLANT OF THIS ANNULOPLASTY RING, THE PATIENT HAD AN ACUTE EVENT AND WAS NOTED TO FALL FROM STANDING WITH OBVIOUS SYMPTOMS OF CEREBROVASCULAR ACCIDENT. IT WAS STATED THAT THE PATIENT DEVELOPED LEFT SIDED WEAKNESS, DYSARTHRIA AND R GAZE PREFERENCE. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED SHOWED RIGHT M1 OCCLUSION, A MECHANICAL THROMBECTOMY WAS PERFORMED AND BLOOD CLOTS WERE REMOVED. IT WAS STATED THAT THE CLOT WAS NOTED TO BE OF AN OLD CONSISTENCY MOST LIKELY CARDIOEMBOLIC AND A COMPUTED TOMOGRAPHY (CT) PERFORMED SHOWED EVOLUTION OF A LARGE ISCHEMIC STROKE. IT WAS REPORTED THAT THE PATIENT REMAINED NEUROLOGICALLY ABNORMAL WITH NO RESPONSE TO ANY EXTERNAL STIMULI PRIOR TO DEATH. THE CAUSE OF DEATH WAS REPORTED AS RESPIRATORY FAILURE (RF).

  Patient problems: Insufficient Information; Respiratory Failure; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 22465296 ↗
• InjuryJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 34MM CG FUTURE RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM DURAN ANCORE BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22370174 ↗
• InjuryJan 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21072621 ↗
• InjuryNov 25, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MILD TO MODERATE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20769904 ↗
• InjuryMar 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM 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 18922154 ↗
• InjuryMar 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, 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 18875724 ↗
• InjuryJan 24, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING THE PATIENT DEVELOPED ATRIOVENTRICULAR (AV BLOCK) OF THE 1ST DEGREE, RESULTING IN PROLONGED HOSPITALIZATION. NO TREATMENT, INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18573058 ↗
• InjuryJan 22, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE REASON FOR REPLACEMENT WAS DUE TO SEVERE REGURGITATION. IT WAS REPORTED THAT THE 34MM MITRAL ANNULOPLASTY RING DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18552455 ↗
• InjuryAug 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15159653 ↗
• InjuryJul 15, 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 34MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE FORMING EFFECT NOT BEING GOOD. IT WAS FURTHER SPECIFIED THAT AFTER IMPLANTING THE RING, THE PATIENT'S VALVE ANNULUS DID NOT FULLY CLOSE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15027440 ↗
• InjuryJun 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14686679 ↗
• InjuryJan 24, 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 34 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; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 13338781 ↗
• InjuryJun 14, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANTATION OF THIS 34MM ANNULOPLASTY BAND, THE SURGEON THOUGHT THAT THERE WAS "POOR FORMING". AS A RESULT THE BAND WAS NOT USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11995468 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information

  MAUDE report 11472660 ↗
• InjuryOct 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34 MM 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: Calcium Deposits/Calcification; Mitral Valve Insufficiency/ Regurgitation; No Information

  MAUDE report 10748897 ↗
• InjurySep 21, 2020Adverse 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 34 MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; No Information

  MAUDE report 10562937 ↗
• InjuryOct 21, 2019Adverse 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 THIS 34MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE DEVICE WAS REPLACED WITH A 33MM MITRAL BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; Muscle Weakness/Atrophy; No Information

  MAUDE report 9214275 ↗
• InjurySep 10, 2019Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Information

  MAUDE report 8982427 ↗
• InjuryAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 30MM MITRAL ANNULOPLASTY RING OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS RESIDUAL MITRAL REGURGITATION. THE PHYSICIAN STATED THAT THERE WERE NO ISSUES WITH THE RING ITSELF. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 8883507 ↗
• InjuryMar 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8436900 ↗