CG FUTURE™ 638RL36Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169793569), received between Jul 30, 2020 and Jul 23, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 7 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22577164 ↗
• InjuryApr 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 36MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE SURGEON HAD CUT THE BAND TO "MAKE IT FIT A LITTLE BETTER" OFF LABEL. THE SURGEON CLARIFIED THEY CUT THE FLEXIBLE ARM OF THE BAND ITSELF. THE SURGEON WAS INFORMED THIS IS OFF LABEL USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19012086 ↗
• InjuryFeb 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING AND 36MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT AN ELECTROCARDIOGRAM (ECG) DISCOVERED ATRIO-VENTRICULAR BLOCK III (AV BLOCK III). SUBSEQUENTLY 5 DAYS LATER, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS AV BLOCK III. IT WAS ALSO REPORTED THAT THE PATIENTS HOSPITAL ADMISSION WAS PROLONGED DUE TO THIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 18663305 ↗
• InjuryOct 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 6 MONTHS POST IMPLANT OF THIS 36MM 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 15527959 ↗
• InjuryAug 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 3 MONTHS POST IMPLANT OF THIS 36MM 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 12372311 ↗
• InjuryFeb 17, 2021Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE 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 11339392 ↗
• InjuryJul 30, 2020Inadequacy 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 DURING THE IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 32MM ANNULOPLASTY RING OF THE SAME MODEL. IT WAS REPORTED THE 36MM ANNULOPLASTY RING WAS REPLACED BECAUSE THE SURGEON FELT IT WAS TOO LARGE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ischemia; No Consequences Or Impact To Patient

  MAUDE report 10344061 ↗