Duran AnCore™ 620BG35Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00643169793491), received between Sep 18, 2018 and Aug 23, 2026 — classified as 34 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (25 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  Medtronic received information that 5 weeks post implant of this 35mm Duran AnCore annuloplasty heart band, it was explanted and replaced with a 31mm Duran AnCore annuloplasty heart ring. The reason for the replacement was not reported. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50397522 ↗
• InjuryMar 30, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 3 YEARS AND 3 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 2 6MM MITRAL ANNULOPLASTY RING OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24727360 ↗
• MalfunctionSep 9, 2025Positioning Failure; Unintended Movement; Activation Failure; Positioning Failure; Unintended Movement; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX WITH SHIELD (PED2-475-25) STENT TIP WOULD NOT OPEN AND A MARKSMAN MICROCATHETER TIP WAS DEFORMED. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, AMORPHOUS, LEFT INTERNAL CAROTID ARTERY C6 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 7.1 MM AND A 6.1 MM NECK DIAMETER. THE ARTERIAL LANDING ZONE DIAMETER WAS 4.3 MM DISTALLY AND 4.7 MM PROXIMALLY. THE ICA ACCESS VESSEL DIAMETER WAS 4.6 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SIGNIFICANT CONTRAST AGENT RETENTION. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). A PIPELINE AND MARKSMAN CATHETER WERE ADVANCED TO THE TARGET LOCATION. ONCE IN PLACE, THE C6-C7 SEGMENT OF THE INTERNAL CAROTID ARTERY WAS RELATIVELY STRAIGHT, SO IN SITU DEPLOYMENT WAS CHOSEN. AFTER CONFIRMING THE ANCHOR POINT BY ANGIOGRAPHY, THE SURGEON BEGAN IN SITU DEPLOYMENT, FIRST EXPOSING THE DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005612 ↗
• InjuryAug 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 35MM DURAN ANCORE HEART BAND, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22814702 ↗
• InjuryJul 24, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 35MM 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; Mitral Valve Insufficiency/ Regurgitation; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 22588310 ↗
• InjuryJul 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 10 MONTHS POST IMPLANT OF THIS DURAN ANCORE HEART 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 22456522 ↗
• InjuryJun 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS 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 22141372 ↗
• InjuryMay 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM 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 22074557 ↗
• InjuryMar 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIOVENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 21678638 ↗
• InjuryMar 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON THE SAME DAY AS THE IMPLANT DATE OF THIS 35MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK AND ATRIAL ARRHYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION, ATRIAL FLUTTER). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Heart Block; Tachycardia

  MAUDE report 21607737 ↗
• InjuryMar 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING AN OPEN HEART PROCEDURE USING THIS 35MM MITRAL ANNULOPLASTY BAND, THE PATIENT DEVELOPED MEDIASTINITIS, MYOCARDITIS AND METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis

  MAUDE report 21607700 ↗
• InjuryJun 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 2 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM BAND OF THE SAME MODEL AND SIZE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19529392 ↗
• InjuryNov 15, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 6 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 32MM ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18142259 ↗
• InjuryOct 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 6 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND IT WAS EXPLANTED AND REPLACED WITH A 35MM ANNULOPLASTY 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 17906136 ↗
• InjuryMay 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 4 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM 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 17011189 ↗
• InjuryMay 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 17007280 ↗
• InjuryApr 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 5 MONTHS POST IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM ANNULOPLASTY 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 16788256 ↗
• InjuryMar 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 16589596 ↗
• InjuryNov 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 35MM 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 15782422 ↗
• InjuryAug 1, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE 35MM BAND BEING TOO LARGE. IT WAS STATED THAT THERE WAS NO MALFUNCTION OF THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15139482 ↗
• InjuryJun 14, 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 3 MONTHS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 28MM ANNULOPLASTY RING. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14685753 ↗
• InjuryMay 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS 4 DAYS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL 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 14468839 ↗
• InjuryJan 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL ANNULOPLASTY BAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13155167 ↗
• InjuryAug 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 35MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED. THE PACKAGE FORM STATED, "OPENED, ATTEMPTED, EXPLANTED". THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12318568 ↗
• InjuryJun 25, 2021Adverse 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 35MM MITRAL ANNULOPLASTY BAND, IT 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: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 12065813 ↗