Duran AnCore™ 620BG31Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169793477), received between Oct 23, 2018 and Jul 10, 2025 — classified as 1 death, 18 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS DURAN ANCORE 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 22467528 ↗
• InjuryMar 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 31MM MITRAL DURAN ANCORE ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL DURAN ANCORE BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS WASTED.

  Patient problems: Insufficient Information

  MAUDE report 21571796 ↗
• InjuryMar 10, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT POST REPAIR USING THIS 31MM DURAN ANCORE MITRAL ANNULOPLASTY BAND, THE PATIENT DEMONSTRATED SOME PREMATURE NONSUSTAINED VENTRICULAR BEATS AND CENTRAL LEAK. IT WAS REPORTED THAT UPON INSPECTION, IT WAS NOTED THAT THE PATIENT'S NATIVE MITRAL VALVE DEMONSTRATED PROLAPSE IN THE A3 POSITION. IT WAS STATED THAT THE SURGEON DID NOT FEEL THIS WOULD BE A LONG-TERM RESULT AND ELECTED TO REPLACE THE ANNULOPLASTY BAND WITH A NON-MEDTRONIC MECHANICAL VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Tachycardia

  MAUDE report 21559454 ↗
• InjuryMar 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF A 31MM MITRAL ANNULOPLASTY BAND AND 9 YEARS AND 2 MONTHS POST IMPLANT OF A 23MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 21534839 ↗
• DeathSep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENTS SPOUSE THAT IN AN UNKNOWN DURATION POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED BY THE PATIENTS SPOUSE AS, "COMPLICATIONS OF THE SURGERY". IT WAS ALSO REPORTED BY THE HEALTH CARE PROFESSIONAL (HCP) THAT, "THE DEATH WAS TOTALLY NOT RELATED TO SURGERY". THERE WAS NO EVIDENCE TO SUGGEST THAT THE ANNULOPLASTY BAND OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 17780622 ↗
• InjuryMar 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 9 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, 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

  MAUDE report 16630738 ↗
• InjuryAug 16, 2021Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 25MM BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324148 ↗
• InjuryMar 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 11488046 ↗
• InjuryDec 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS PATIENT UNDERWENT MITRAL VALVE REPAIR SURGERY WITH AN ANNULOPLASTY DEVICE. BOTH A 31MM AND A 27MM ANNULOPLASTY DEVICE OF THE SAME MODEL WERE USED DURING THE SURGERY. IT IS UNKNOWN AT THIS TIME WHICH PRODUCT WAS ATTEMPTED FIRST, AND WHICH PRODUCT REMAINS IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11037537 ↗
• InjuryNov 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 31 MM 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: No Information

  MAUDE report 10796437 ↗
• InjuryOct 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN ANNULOPLASTY BAND OF THE SAME SIZE AND MODEL. IT WAS REPORTED THAT THERE WAS MITRAL REGURGITATION CAUSED BY THE PROGRESSION OF MITRAL VALVE DISEASE WITH PROLAPSE OF THE MEDIAL PART OF THE POSTERIOR LEAFLET. IT WAS ALSO REPORTED THAT THE P2 AND P3 SEGMENTS OF THE POSTERIOR LEAFLET WERE REPAIRED WITH GORE-TEX DURING THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; Mitral Valve Prolapse

  MAUDE report 10765566 ↗
• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 2 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9844837 ↗
• InjuryNov 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Information

  MAUDE report 9295695 ↗
• InjuryOct 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 31MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 9182383 ↗
• InjuryJul 30, 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 IMMEDIATELY POST IMPLANT OF THIS 31MM ANNULOPLASTY BAND, THERE WERE "LEAKS" AROUND IT. THE BAND WAS EXPLANTED AND REPLACED WITH 33MM BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 8843485 ↗
• InjuryJul 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED. ADDITIONALLY, A 38MM ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE, AND EVENTUALLY REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8826243 ↗
• InjuryMay 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 31MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. A NON-MEDTRONIC 33MM BIOPROSTHETIC VALVE WAS ULTIMATELY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8578941 ↗
• InjuryNov 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A 27MM BAND OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8062025 ↗
• InjuryOct 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, TESTING REVEALED RESIDUAL REGURGITATION AT THE COMMISSURES OF THE VALVE. THE SURGEON FELT THAT THE 31MM BAND DID NOT ALLOW FOR ADEQUATE COAPTATION, THEREFORE IT WAS EXPLANTED AND REPLACED WITH A 29MM BAND OF THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7998101 ↗