CG FUTURE® 638RL36 (UDI 00613994758712)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994758712), received between Dec 21, 2016 and Nov 22, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT DURING A PROCEDURE, AN OLD MITRAL HEART RING WAS REMOVED AND REPLACED WITH A MITRAL TISSUE VALVE. THE PROCEDURE INVOLVED THE REMOVAL OF THE EXISTING MITRAL HEART RING AND THE IMPLANTATION OF A NEW MITRAL TISSUE VALVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 20757661 ↗
• InjuryFeb 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT IN AN UNKNOWN DURATION POST IMPLANT OF THIS 36MM 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: Insufficient Information

  MAUDE report 16409187 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 9 MONTHS POST IMPLANT OF THIS 36 MM MITRAL ANNULOPLASTY BAND, 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 14686223 ↗
• InjuryJun 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 2 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM ANNULOPLASTY BAND OF A DIFFERENT MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10212395 ↗
• InjuryMar 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS RESIDUAL MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 9792858 ↗
• InjuryDec 11, 2019Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 7 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND WAS EXPLANTED AND REPLACED WITH A 33MM BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Prolapse; No Information

  MAUDE report 9450929 ↗
• InjuryJul 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 7 MONTHS POST IMPLANT OF THIS 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: Mitral Insufficiency; No Information

  MAUDE report 8843154 ↗
• InjuryDec 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT MONTHS AND TEN DAYS FOLLOWING THE IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM ANNULOPLASTY BAND. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8145258 ↗
• InjurySep 15, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT THIS ANNULOPLASTY RING WAS "WASTED" AND EXPLANTED ON THE DAY OF IMPLANT. THE REASON THE DEVICE WAS "WASTED" AND EXPLANTED IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6869591 ↗
• InjuryMay 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS ANNULOPLASTY RING, THIS DEVICE WAS EXPLANTED. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6565110 ↗
• InjuryMay 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 4 MONTHS POST IMPLANT OF THIS 36 MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29 MM BIOPROSTHETIC VALVE. NO FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6545082 ↗
• InjuryMay 3, 2017Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY ONE YEAR, SIX MONTHS POST IMPLANT OF THIS ANNULOPLASTY RING IN THE MITRAL POSITION, THIS RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fatigue; Mitral Insufficiency; No Information

  MAUDE report 6540760 ↗
• InjuryFeb 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 11 MONTHS POST IMPLANT OF THIS 36MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 35MM ANNULOPLASTY DEVICE. NO FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6355018 ↗
• InjuryDec 21, 2016Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY ONE MONTH POST IMPLANT OF THIS ANNULOPLASTY RING IN THE MITRAL POSITION, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A MECHANICAL MITRAL VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Mitral Regurgitation; No Information

  MAUDE report 6195082 ↗