PROFILE 3D® 680R36Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994759207), received between Oct 10, 2017 and Dec 23, 2025 — classified as 1 death, 9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 12 YEARS AND 1 MONTH POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23877954 ↗
• InjuryMay 25, 2021Adverse 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 36MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11876122 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK (CHB) NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 11375217 ↗
• DeathAug 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM A PATIENT'S HUSBAND THAT THE PATIENT DIED 11 DAYS POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND. THE HUSBAND REPORTED THAT "THE DEVICE WAS PART OF THE SURGERY THAT FAILED". NO FURTHER DETAILS WERE PROVIDED. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 10442980 ↗
• InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 49 DAYS POST IMPLANT OF THIS 36MM ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 8331654 ↗
• InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOUR DAYS POST IMPLANT OF THIS ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO SINUS NODE DYSFUNCTION AND UNSPECIFIED ATRIAL ARRHYTHMIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 7957456 ↗
• InjuryJun 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 DAYS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 35MM MITRAL ANNULOPLASTY BAND FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7609700 ↗
• InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS ANNULOPLASTY RING, THE ELECTROCARDIOGRAM (ECG) SHOWED COMPLETE HEART BLOCK (CHB). EIGHT DAYS POST IMPLANT A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block; Non specific EKG/ECG Changes

  MAUDE report 7508996 ↗
• InjuryFeb 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS POST IMPLANT OF THIS 36 MM ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACE WITH A DIFFERENT MODEL 29 MM ANNULOPLASTY BAND DUE TO SYSTOLIC ANTERIOR MOTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7264672 ↗
• InjuryOct 10, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT THIS ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE AS THE PHYSICIAN WAS UNHAPPY WITH THE WAY THE ATTEMPTED REPAIR LOOKED. THE DEVICE WAS REPLACED WITH A BIOPROSTHETIC VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 6935901 ↗