CG FUTURE® 638RL32 (UDI 00613994758675)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00613994758675), received between Jan 17, 2017 and Oct 22, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS POST IMPLANT OF THIS 32MM 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 23360844 ↗
• InjuryApr 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 19069655 ↗
• InjuryNov 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 3 MONTHS POST IMPLANT OF THIS 32MM 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

  MAUDE report 12851912 ↗
• InjuryOct 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS 9 MONTHS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Stenosis; No Information

  MAUDE report 9182451 ↗
• InjuryDec 19, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT THIS ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. WHILE THE PHYSICIAN WAS SUTURING THE RING INTO THE PATIENT, THE SUTURES "BROKE". THE RING WAS SUCCESSFULLY REPLACED WITH A MITRAL BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8181694 ↗
• InjuryMar 9, 2018Adverse 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 MITRAL ANNULOPLASTY RING, A TISSUE VALVE WAS IMPLANTED IN THE SAME POSITION. THE SURGEON INDICATED THERE WAS A 7 BY 3 MM PERFORATION AT THE ANNULAR BASE OF THE P2 LEAFLET. THE CUSTOMER STATED THAT THERE WERE NO ISSUES WITH THE ANNULOPLASTY RING ITSELF AND THAT IT WAS A PATIENT ISSUE THAT CAUSED THE LEAFLET TO EXTRACT FROM THE ANNULUS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7327180 ↗
• InjuryFeb 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED A CALL FROM A PATIENT WHO REPORTED THAT THIS MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE DEVICE WAS REPLACED WITH ANOTHER MITRAL ANNULOPLASTY RING FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7270984 ↗
• InjuryJan 16, 2018Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7192913 ↗
• InjuryDec 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 32MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE DEVICE WAS REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7147501 ↗
• InjuryDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS ANNULOPLASTY RING, THE PHYSICIAN NOTED THAT DUE TO PATIENT ANATOMY ABNORMALITY, THE RING COULD NOT BE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: High Blood Pressure/ Hypertension; Rheumatic Heart Disease

  MAUDE report 7105697 ↗
• InjuryNov 16, 2017Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 2 MONTHS POST IMPLANT, THIS 32MM MITRAL ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A 28MM ANNULOPLASTY RING DUE TO PARAVALVULAR LEAK (PVL). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Regurgitation

  MAUDE report 7038561 ↗
• InjurySep 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. AFTER IMPLANT THE PHYSICIAN OBSERVED A LARGE LEAK AS THE PATIENTS ANNULUS WAS TOO LARGE FOR THE RING. THE RING WAS THEN EXPLANTED AND REPLACED WITH A MITRAL BIOPROSTHETIC VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 6891366 ↗
• InjurySep 18, 2017Adverse 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 AFTER IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE PHYSICIAN WAS NOT SATISFIED WITH THE COMPETENCY OF THE VALVE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC MECHANICAL VALVE DURING THE SAME POSITION. THE PHYSICIAN STATED THAT THERE WAS NO FAILURE OF THE DEVICE BUT RATHER THAT HE MISJUDGED THE REPAIRABILITY OF THE NATIVE TISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6872186 ↗
• InjuryJun 2, 2017Adverse 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, THE PHYSICIAN NOTED MODERATE TO SEVERE PERSISTENT MITRAL REGURGITATION ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AFTER THE PATIENT WAS TAKEN OFF OF CARDIOPULMONARY BYPASS (CPB). THE PATIENT WAS PLACED BACK ON CPB, AND THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. PATIENT MEDICAL HISTORY: HISTORY OF RECURRENT MIGRAINE; TEMPOROMANDIBULAR JOINT SYNDROME; MAZE PROCEDURE.

  Patient problems: Mitral Regurgitation

  MAUDE report 6608443 ↗
• InjuryMay 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 2 MONTHS POST IMPLANT OF THIS ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6579910 ↗
• InjuryJan 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, THE DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6257552 ↗
• InjuryJan 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE PATIENT HAD SEVERE MITRAL REGURGITATION CAUSED BY A SIGNIFICANT DETERIORATION OF THE MITRAL REPAIR AND A VERY REDUNDANT ANTERIOR LEAFLET. THE DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; Mitral Valve Prolapse

  MAUDE report 6257091 ↗