Duran AnCore® 620RG25 (UDI 00613994758927)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994758927), received between Mar 7, 2017 and Oct 11, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 9 MONTHS POST IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20429257 ↗
• InjurySep 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS POST IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY RING, AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED. THE REASON FOR THE ICD WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 20148268 ↗
• InjuryDec 22, 2020Material Separation; Inadequacy of Device Shape and/or Size; Material Separation; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 20 DAYS POST IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. IT WAS REPORTED THAT THE RING HAD BECOME TOO SMALL FOR THE PATIENT AND WAS CAUSING MITRAL STENOSIS. IT WAS ALSO REPORTED THAT THE ANTERIOR ANNULAR PART OF THE RING WAS DETACHED FROM THE MITRAL ANNULUS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 11055861 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 25MM BIOPROSTHETIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 9598453 ↗
• InjuryFeb 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8346494 ↗
• InjuryMar 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 5 YEARS AND 8 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 7323135 ↗
• InjuryNov 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. AFTER IMPLANT, THE PATIENTS VALVE WAS TESTED AND SHOWED THAT DUE TO THE PATIENTS NATIVE VALVE BEING SO DAMAGED, THAT THE RING COULD NOT REPAIR IT. THE DEVICE WAS REPLACED WITH A MITRAL BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7018683 ↗
• InjuryMar 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS POST IMPLANT OF THIS ANNULOPLASTY RING, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC MITRAL VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6385812 ↗