Duran AnCore™ 620BG25Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169793446), received between Mar 11, 2019 and Sep 11, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 9 most recent of 9 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 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS 25MM DURAN ANCORE HEART BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM DURAN ANCORE HEART BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23027296 ↗
• InjuryOct 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 10 MONTHS POST IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20471414 ↗
• InjuryDec 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY BAND, 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 18345612 ↗
• InjuryDec 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 5 MONTHS POST IMPLANT OF THIS 25MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE INDICATED FOR THE MITRAL POSITION. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16016740 ↗
• InjuryJan 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13260462 ↗
• InjuryJan 4, 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 DURING THE IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC DEVICE. THE REASON FOR THE REPLACEMENT WAS REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13151857 ↗
• InjurySep 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THIS MITRAL VALVE SURGERY A 25MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND THEN IMMEDIATELY EXPLANTED. THE REASON FOR REPLACEMENT WAS REPORTED AS "FAILED REPAIR DUE TO PATIENTS ANATOMY". IT WAS ALSO REPORTED THAT THE ANNULOPLASTY PRODUCT DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12490663 ↗
• InjurySep 13, 2021Gradient Increase; Adverse Event Without Identified Device or Use Problem; Gradient Increase; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC VALVE. IT WAS REPORTED THAT THE REPAIR ATTEMPT WITH THE ANNULOPLASTY DEVICE WAS NOT SUCCESSFUL DUE TO THE PATIENT'S ANATOMY, AND THAT THE EVENT WAS NOT RELATED TO THE PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 12461450 ↗
• InjuryMar 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS ANNULOPLASTY BAND IN THE TRICUSPID POSITION, THE BAND 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 8409502 ↗