CG FUTURE™ 638RL32Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00643169793545), received between Mar 15, 2018 and Jun 5, 2026 — classified as 55 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (33 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 59 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS VALVE PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AFTER IMPLANT, THE PATIENT STILL EXHIBITED SEVERE MITRAL REGURGITATION. THE ANNULOPLASTY RING WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 25411343 ↗
• InjuryDec 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM CG FUTURE RING, IT WAS EXPLANTED AND REPLACED WITH A 34MM DEVICE FROM A DIFFERENT MANUFACTURER. THE REASON FOR THE REPLACEMENT WAS REPORTED THAT AFTER IMPLANTATION OF THE CG FUTURE DEVICE, A TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED SYSTOLIC ANTERIOR MOTION (SAM). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23851138 ↗
• InjuryDec 1, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE ANNULOPLASTY PRODUCT DID NOT MALFUNCTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23679139 ↗
• InjuryNov 4, 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 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A M ECHANICAL VALVE PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AFTER ANNULOPLASTY RING IMPLANT, THE NATIVE VALVE LEAFLETS DID NOT COAPT WELL. THE ANNULOPLASTY RING WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23469198 ↗
• InjuryOct 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23290289 ↗
• InjurySep 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 5 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIOVENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22953366 ↗
• InjuryJul 25, 2025Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM CG FUTURE RING, IT WAS EXPLANTED AND REPLACED WITH ANOTHER CG FUTURE RING. THE REASON FOR THE REPLACEMENT WAS REPORTED AS A BROKEN SUTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22609332 ↗
• InjuryJul 3, 2025Incomplete Coaptation; Incomplete Coaptation

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

  Patient problems: Insufficient Information

  MAUDE report 22393674 ↗
• InjuryMay 26, 2025Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM CG FUTURE RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS "THE VALVE RING WAS FOUND TO BE SEVERELY DEFORMED AND COULD NOT BE USED". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22084381 ↗
• MalfunctionNov 14, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM ANNULOPLASTY RING, IT WAS REPLACED WITH THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE "... CG FORMING RING WAS SOLID DURING THE WIRING PROCESS ON THE CG FUTURE FORMING RING. THE SUTURE BETWEEN THE HOLDER AND THE ANNULOPLASTY RING BROKE DURING SUTURING, AND (HCP) REPLACED IT WITH A NEW (SAME PRODUCT). THE ANNULOPLASTY PRODUCT WAS NOT FULLY SUTURED AND TESTED PRIOR TO REMOVAL. IT WAS NOTED THAT THE PATIENT WAS NOT AFFECTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20687620 ↗
• InjuryOct 31, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN ANNULOPLASTY RING OF A DIFFERENT MANUFACTURER. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE SHAPE OF THE RING FRAME WAS DISTORTED AND DEFORMED, SO ANOTHER PRODUCT WAS USED INSTEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20576891 ↗
• InjuryOct 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32 MM ANNULOPLASTY RING, IT WAS REPLACED WITH ANOTHER RING OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE RING FELL OFF FROM THE HANDLE AND "FELL OFF FROM THE FIXATION PLATE" AND "COULD NOT BE IMPLANTED SMOOTHLY." IT WAS REPORTED THAT THE RING WAS SUSPENDED BY THE SUTURES IN THE CHEST CAVITY. IT WAS STATED THAT THE RING WAS NOT FULLY SUTURED AND WAS "REMOVED IMMEDIATELY AFTER FALLING OFF." IT WAS STATED THAT THERE WERE NO ISSUES NOTED WITH THE HANDLE. IT WAS NOTED THAT THERE WAS A DELAY OF 5 MINUTES TO THE SURGERY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20514950 ↗
• MalfunctionSep 3, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS REPLACED WITH A 32MM ANNULOPLASTY RING OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS WHEN THE SURGEON WAS ATTEMPTING TO IMPLANT THE ANNULOPLASTY RING, IT WAS DISCOVERED THAT THE BUCKLE SUTURE ON THE RING FIXATOR WAS BROKEN. IT WAS INDICATED THAT THE DEVICE HAD BEEN INSPECTED UPON REMOVAL FROM ITS PACKAGING WITH NO ISSUES NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127471 ↗
• MalfunctionAug 26, 2024Material Frayed; Material Frayed

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THIS 32MM ANNULOPLASTY RING, IT WAS REPLACED WITH A 32MM ANNULOPLASTY RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE RINGS BRAIDED LOOP HAD BURRS OR FRAYED SEWING EDGES NEAR THE FRONT OF THE RING. IT WAS FURTHER CLARIFIED THAT THE DEVICE HAD FRAYED THREADS/MATERIAL ON THE SEWING CUFF OF THE RING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20065137 ↗
• InjuryAug 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM 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 19959127 ↗
• InjuryJul 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS INDICATED THAT IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. IT WAS STATED THAT THE RING WAS "NOT RETAINED." THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19794269 ↗
• MalfunctionJul 12, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS REPLACED WITH A RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE BUCKLE RING SUTURE WAS BROKEN WHILE WIRING ON THE CG FORMING RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730738 ↗
• InjuryMay 23, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SYMPTOMATIC SEVERE MITRAL REGURGITATION (MR), AN EJECTION FRACTION OF 53% AND FLAIL POSTERIOR LEAFLET. IT WAS ALSO REPORTED, "NOTHING WRONG WITH RING". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19381621 ↗
• InjuryMay 21, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS NOT IMPLANTED, IT WAS REPLACED WITH A RING OF THE SAME MODEL AND SIZE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE BUCKLE SUTURE WAS BROKEN. IT WAS STATED THAT "THE WIRE WAS PUT FOR THE RING DURING THE IMPLANTATION PROCESS" TO FIX THE DEVICE TO THE VALVE AND IT WAS FOUND THAT THE BUCKLE SUTURE ON THE FORMING RING FIXATOR HOLDER WAS BROKEN. THE RING WAS INSPECTED UPON REMOVAL FROM PACKAGING AND NO ISSUES WERE NOTED AT THAT TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19360404 ↗
• InjuryOct 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN MEDTRONIC DEVICE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AFTER SUTURING, THE ANNULOPLASTY RING HAD POOR FORMATION EFFECT AND WAS NOT GOOD. IT WAS ALSO REPORTED THAT THE ANNULOPLASTY RING WAS NOT AN INCORRECT SIZE AND DID NOT MALFUNCTION. IT IS UNKNOWN IF THE PATIENT HAD ANY PRE-EXISTING CONDITIONS OR ANATOMICAL FACTORS THAT MAY HAVE ATTRIBUTED TO THIS EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17987212 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM 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 17859556 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, FIRST DEGREE ATRIOVENTRICULAR BLOCK WITH FREQUENT SUPRAVENTRICULAR PREMATURE COMPLEXES WAS OBSERVED. IT WAS STATED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION POST- OPERATIVELY. IT WAS NOTED THAT THE PATIENT SPENT AN EXTENDED TIME IN THE INTENSIVE CARE UNIT WITH WHAT APPEARED TO BE TACHYBRADYCARDIA SYNDROME. APPROXIMATELY, ONE YEAR LATER, THE PATIENT UNDERWENT A MAZE PROCEDURE TO ADDRESS THE ATRIAL FIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Non specific EKG/ECG Changes

  MAUDE report 17662848 ↗
• InjuryJul 5, 2023Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 10 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, 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; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17262309 ↗
• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM AORTIC 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 16853802 ↗
• InjuryMar 23, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN ANNULOPLASTY RING OF THE SAME MAKE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS IT WAS NOTED THAT THE IMPLANTED FORMED RING DID NOT MATCH AFTER HAVING BEEN SIZED WITH THE MEASURER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16599483 ↗