PROFILE 3D® 680R24Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994759269), received between Aug 7, 2017 and Sep 11, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 24MM PROFILE 3D HEART 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 23027888 ↗
• InjuryJul 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS POST IMPLANT OF THIS 24MM 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

  MAUDE report 22522969 ↗
• InjuryMar 21, 2022Adverse 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 3 YEARS AND 1 MONTH POST IMPLANT OF THIS 24MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 25MM MITRAL 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 13840795 ↗
• InjuryJul 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 24MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10350057 ↗
• InjuryJun 5, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS AND TEN MONTHS POST IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE DUE TO PANNUS. THE SURGEON REPORTED THAT THE PANNUS CAUSED STENOSIS AND CONSTRICTION OF THE LEAFLETS WITH DISTORTION AND INCOMPETENCE OF THE NATIVE VALVE. THE SURGEON REPORTED THE RING WAS WELL SEATED WITH NO PARAVALVULAR LEAK (PVL) AND THAT THE ISSUE WAS CAUSED BY THE PANNUS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Corneal Pannus; Mitral Insufficiency; Mitral Valve Stenosis

  MAUDE report 8672083 ↗
• InjuryAug 7, 2017Gradient Increase; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Gradient Increase; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR 2 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; Mitral Valve Stenosis; No Information

  MAUDE report 6770935 ↗