CG FUTURE® 638RL34Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00613994758699), received between Sep 11, 2017 and Jul 16, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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.

• InjuryJul 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 5 MONTHS POST IMPLANT OF THIS 34MM CG FUTURE HEART RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM OPEN PIVOT MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22517446 ↗
• InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS CG FUTURE RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS BRADYCARDIA AND TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 22517148 ↗
• InjuryMar 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 9 MONTHS POST IMPLANT OF THIS 34MM CG FUTURE MITRAL BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM MOSAIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21534642 ↗
• InjuryAug 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 3 MONTHS POST 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 17609955 ↗
• InjurySep 29, 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 A 31 MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10604177 ↗
• InjuryJun 16, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 34MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED. IT IS UNKNOWN AS TO WHAT PRODUCT IT WAS REPLACED WITH. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 10160828 ↗
• InjuryJun 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 10 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10135238 ↗
• InjuryDec 10, 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 DURING THE IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE SURGEON WAS ATTEMPTING TO REPAIR THE MITRAL VALVE AND REPORTED THAT POST IMPLANT THERE WAS PERSISTENT MODERATE REGURGITATION. AS A RESULT, THE RING WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC ANNULOPLASTY RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 9444658 ↗
• InjuryNov 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiogenic Shock; No Information

  MAUDE report 9335285 ↗
• InjuryAug 28, 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 NON-MEDTRONIC MECHANICAL VALVE. IT WAS REPORTED THAT THE RING REPAIR WAS UNSUCCESSFUL DUE TO BILEAFLET PROLAPSE. THE PHYSICIAN NOTED THERE WAS EXTENSIVE NATIVE TISSUE, THICKENED NATIVE LEAFLETS, CHORDAL LENGTHENING, AND NO ISSUE WITH THE ANNULOPLASTY BAND. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Prolapse

  MAUDE report 8941870 ↗
• InjuryJan 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 8 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A 27MM ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Insufficiency; Mitral Valve Prolapse; No Information

  MAUDE report 8275416 ↗
• InjuryAug 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 8 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7812456 ↗
• InjuryJun 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS 34MM ANNULOPLASTY RING IN THE MITRAL POSITION, THE RING WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE DUE TO SEVERE RESIDUAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7641741 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34 MM ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A 31 MM NON-MEDTRONIC PRODUCT. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 7615965 ↗
• InjuryMay 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7509216 ↗
• InjuryFeb 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 34MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. A BIOPROSTHETIC VALVE WAS IMPLANTED IN ITS PLACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 7267576 ↗
• InjurySep 11, 2017Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS 9 MONTHS POST IMPLANT OF THIS MITRAL HEART RING, THE DEVICE WAS REPLACED DUE TO PARAVALVULAR LEAK AND MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 6856160 ↗