Duran AnCore® 620BG35 (UDI 00613994759160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00613994759160), received between Jan 30, 2017 and May 21, 2026 — classified as 36 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (24 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 5 YEARS AND 6 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 25243401 ↗
• InjuryApr 21, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 9 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24940925 ↗
• InjuryJul 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN IMPLANTED MITRAL HEART BAND WAS EXPLANTED AND A NEW MITRAL TISSUE VALVE WAS IMPLANTED IN THE MITRAL POSITION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22387104 ↗
• InjuryOct 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 35 MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 32 MM RING OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20462888 ↗
• InjuryAug 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 10 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, A REPLACEMENT DEFIBRIL LATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY, ATRIAL FLUTTER, ATRIAL TACHYCARDIA AND ATRIAL FIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Cardiomyopathy; Tachycardia

  MAUDE report 19982628 ↗
• InjuryAug 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 11 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19959188 ↗
• InjuryJun 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 5 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.  .

  Patient problems: Insufficient Information

  MAUDE report 19568764 ↗
• InjuryJun 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 14 DAYS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS SPONTANEOUS SUSTAINED VENTRICULAR TACHYCARDIA (V-TACH). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tachycardia

  MAUDE report 19509282 ↗
• InjuryMay 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 5 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 19351791 ↗
• InjuryMay 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 4 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM BAND OF THE SAME MAKE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17030580 ↗
• InjurySep 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 8 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15361469 ↗
• InjuryAug 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 8 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15139704 ↗
• InjuryMay 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 7 MONTHS POST IMPLANT OF THIS 35MM 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 14459080 ↗
• InjuryMay 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 3 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11879309 ↗
• InjuryApr 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 8 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11656914 ↗
• InjuryNov 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 10868151 ↗
• InjuryApr 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 3 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8564851 ↗
• InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS 9 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED DUE TO SEVERE MITRAL INSUFFICIENCY FROM CHRONIC MYXOMATOUS DEGENERATION. A NON MEDTRONIC DEVICE WAS SUCCESSFULLY IMPLANTED IN ITS PLACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Insufficiency; Mitral Valve Prolapse

  MAUDE report 7754138 ↗
• InjuryJun 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 9 MONTHS POST IMPLANT OF THIS 35 MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29 MM MITRAL ANNULOPLASTY BAND FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7641069 ↗
• InjuryApr 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 7393536 ↗
• InjuryMar 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, THE BAND WAS IMPLANTED AND THEN REPLACED WITH A 29MM BAND. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 7387173 ↗
• InjuryMar 6, 2018Adverse 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 THIS ANNULOPLASTY RING, IMPLANTED AN UNKNOWN DURATION, WAS SUBSEQUENTLY EXPLANTED FOR UNKNOWN REASONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7318948 ↗
• InjuryNov 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 3 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND WAS EXPLANTED AND REPLACED FOR UNKNOWN REASONS. A NEW 29MM MITRAL ANNULOPLASTY BAND WAS OPENED BUT ULTIMATELY NOT USED, EVENTUALLY THE PATIENT RECEIVED A COMPETITOR DEVICE IN ITS PLACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 7044852 ↗
• InjuryOct 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. IT WAS REPORTED THAT THE REPAIR ATTEMPT WAS UNSUCCESSFUL BUT THERE WAS NO ALLEGATION AGAINST THE ANNULOPLASTY DEVICE ITSELF. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 6967344 ↗
• InjuryAug 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 16 DAYS POST IMPLANT OF THIS ANNULOPLASTY BAND, THE DEVICE WAS REPLACED DUE TO UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information; Tricuspid Regurgitation

  MAUDE report 6811930 ↗