PROFILE 3D® 680R40Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994759184), received between Mar 16, 2017 and May 15, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Intravalvular regurgitation” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 40MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT A T RANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DISCOVERED SEVERE RECURRENT MITRAL REGURGITATION. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19319900 ↗
• InjuryFeb 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 40MM MITRAL ANNULOPLASTY RING, THE PATIENT DEVELOPED POSTOPERATIVE ATRIAL FIBRILLATION. THE PATIENT WAS TREATED WITH MEDICATION. NO INTERVENTIONS OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 18738067 ↗
• InjuryOct 26, 2023Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 40MM MITRAL ANNULOPLASTY RING, TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED MODERATE MITRAL INSUFFICIENCY. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, AT THE PATIENT'S 2 YEAR FOLLOW-UP IT WAS NOTED THAT STENOSIS, AND SEVERE MITRAL INSUFFICIENCY ARE PRESENT. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 18015150 ↗
• InjuryMar 16, 2017Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED BECAUSE IT WAS THE INCORRECT SIZE FOR THE PATIENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6411975 ↗