Duran AnCore® 620RG31 (UDI 00613994758989)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00613994758989), received between Feb 23, 2017 and Jul 29, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Patient Device Interaction Problem

  It was reported that 2 years and 10 months post implant of this 31mm tricuspid annuloplasty ring and 31mm mitral bioprosthetic valve, a defibrillator was implanted. The reason for the defibrillator was reported as low ejection fraction (EF). No additional adverse patient effects were reported.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50065958 ↗
• InjuryJan 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 6 MONTHS POST IMPLANT OF THIS 31 MM MITRAL ANNULOPLASTY RING, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 21056152 ↗
• InjuryApr 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY RING, 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 16728589 ↗
• InjuryJun 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 6 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14681102 ↗
• InjuryNov 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 1 MONTH POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 36MM  MITRAL ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body Reaction; Insufficient Information; Mitral Valve Stenosis

  MAUDE report 12851576 ↗
• InjuryJun 16, 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 5 YEARS AND 5 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 25MM 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; Mitral Valve Stenosis

  MAUDE report 12008983 ↗
• InjuryNov 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY RING, 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: No Information

  MAUDE report 10778487 ↗
• InjuryJun 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT IMMEDIATELY POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10157898 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING AN ANNULOPLASTY RING IMPLANT FOR A MITRAL VALVE REPAIR, IT WAS NOTED THAT THERE WERE RUPTURED AND ELONGATED CHORDAE TENDINEAE AS WELL AS BOWING AND POSSIBLE POSTERIOR LEAFLET PROLAPSE. AFTER PLACEMENT OF THE RING, A SIGNIFICANT LEAK WAS NOTED AND THE RESIDUAL LEAK PERSISTED DESPITE REPAIR ATTEMPTS. DUE TO REGURGITATION, IT WAS DECIDED TO EXPLANT THE RING AND IMPLANT A BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 10058788 ↗
• InjuryMar 11, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 31 MM MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A 29 MM RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8409790 ↗
• InjuryJan 10, 2019Adverse 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 APPROXIMATELY 2 YEARS 4 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED DUE TO UNKNOWN REASONS. THE REPLACEMENT PRODUCT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8237539 ↗
• InjuryNov 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 10 MONTHS POST IMPLANT OF THIS 31MM TRICUSPID ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A 29MM TRICUSPID BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 8117915 ↗
• InjuryApr 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 10 MONTHS POST IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7458852 ↗
• InjuryJan 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 31MM ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN NON-MEDTRONIC DEVICE DUE TO MITRAL REGURGITATION. THE PHYSICIAN STATED THAT THE RING WAS NOT ABLE TO RESOLVE THE REGURGITATION DUE TO A LEAFLET ISSUE WITH THE NATIVE MITRAL VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7178845 ↗
• InjuryNov 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A NON- MEDTRONIC 29 MM VALVE. AFTER IMPLANT OF THE BAND, THE PHYSICIAN DETERMINED THAT THE REPAIR DID NOT RESOLVE THE PATIENT'S ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7024758 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE PROCEDURE TO IMPLANT THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC VALVE. THERE WAS NO FAILURE OF THE RING. IT WAS REPLACED DUE TO SYSTOLIC ANTERIOR MOTION (SAM). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6930201 ↗
• InjuryAug 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED ON THE SAME DAY FOR UNKNOWN REASONS. THE DEVICE WAS REPLACED WITH A BIOPROSTHETIC VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6824485 ↗
• InjuryMay 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS 9 MONTHS POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, THE DEVICE WAS EXPLANTED AND REPLACED WITH AN ANNULOPLASTY RING FOR UNKNOWN REASONS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6553317 ↗
• InjuryMar 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS 31 MM ANNULOPLASTY RING IN THE MITRAL POSITION, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A 29 MM ANNULOPLASTY RING. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6429884 ↗
• InjuryFeb 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS, NINE MONTHS POST IMPLANT OF THIS ANNULOPLASTY RING, THIS DEVICE WAS EXPLANTED AND REPLACED BY A MECHANICAL HEART VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6354932 ↗