Duran AnCore® 620BG27 (UDI 00613994759085)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00613994759085), received between Jul 11, 2017 and Mar 6, 2026 — classified as 1 death, 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 14 YEARS AND 9 MONTHS POST IMPLANT OF THIS 27MM AORTIC ANNULOPLASTY BAND, A 26MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24529072 ↗
• InjuryJul 2, 2025Material Separation; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Material Separation; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 4 MONTHS POST IMPLANT OF THIS 27MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22385207 ↗
• InjuryApr 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 10 MONTHS POST IMPLANT OF THIS DURAN ANCORE MITRAL BAND, 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 21752898 ↗
• DeathJan 21, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 27MM MITRAL DURAN ANCORE ANNULOPLASTY BAND DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE ANNULOPLASTY BAND COULD NOT BE EXCLUDED. IT WAS STATED THAT PRIOR TO DEATH, THE PATIENT WAS IN CARDIAC ARREST, AND ACTIVE CARDIOPULMONARY RESUSCITATION WAS BEING PERFORMED. UPON ARRIVAL TO THE FACILITY, THERE WAS NO HEART RATE DETECTED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Cardiac Arrest

  MAUDE report 21195905 ↗
• InjuryJan 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 6 MONTHS POST IMPLANT OF THIS 27MM MITRAL ANNULOPLASTY BAND, A REPLACEMENT DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE REPLACEMENT DEFIBRILLATOR WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 21159344 ↗
• InjuryJan 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT DID NOT HAVE ANY PRE-EXISTING ARRHYTHMIAS PRIOR TO THE HEART VALVE IMPLANT AND THE PHYSICIAN DOES NOT BELIEVE THE HEART VALVE OR IMPLANT PROCEDURE CAUSED OR CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 21159303 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THIS MITRAL VALVE SURGERY A 29MM 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 12490661 ↗
• InjuryJan 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 2 YEARS AND 2 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, 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: Insufficient Information

  MAUDE report 11155845 ↗
• InjuryJul 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 27MM MITRAL ANNULOPLASTY BAND, THERE WAS MODERATE TO SEVERE REGURGITATION NOTED. THE SURGEON STATED THAT THE BAND DID NOT ADEQUATELY REPAIR THE PATIENT'S NATIVE VALVE AND THAT THERE WAS AN ATRIAL MASS REMOVED AT THE SAME TIME, WHICH LIKELY COMPLICATED THE REPAIR. A NON MEDTRONIC VALVE WAS SUCCESSFULLY IMPLANTED IN ITS PLACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 10338864 ↗
• InjuryJan 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 27 MM ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A 29 MM BIOPROSTHETIC VALVE. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficiency, Valvular; No Information

  MAUDE report 7203781 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 27 MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7070659 ↗
• InjuryNov 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 6 MONTHS POST IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED FOR UNKNOWN REASONS AND REPLACED WITH A BIOPROSTHETIC VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Zonular Dehiscence

  MAUDE report 7022448 ↗
• InjuryJul 11, 2017Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT OF THIS ANNULOPLASTY BAND IN THE MITRAL POSITION, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 6701982 ↗