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Duran AnCore™ 620BG23Recalls & reported problems

Medtronic, Inc. · BAND 620BG23 DURAN ANCORE ANNULO 29L · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169793439), received between Oct 6, 2020 and Oct 8, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Insufficient Device Problem Information1

Patient problems

  • Mitral Regurgitation2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 23MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 25MM BIOPROSTHETIC VALVE. IT WAS REPORTED THAT THERE WAS TRACE MITRAL REGURGITATION FOLLOWING THE REPAIR, BUT THE REGURGITATION HAD ADVANCED TO SEVERE BY THE FOLLOWING DAY. IT WAS ALSO REPORTED THAT THERE WAS DEMONSTRATED DEHISCENCE OF THE PATCH APPLIED TO THE POSTERIOR LEAFLET. THEREFORE, THE PATIENT'S NATIVE VALVE COULD NOT BE REPAIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Mitral Regurgitation

    MAUDE report 10648714 ↗
  • InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 23 MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 23 MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. IT WAS REPORTED THAT THE REASON FOR REPLACEMENT WAS DUE TO "SIGNIFICANT MITRAL REGURGITATION". IT WAS REPORTED THAT THE BAND WAS SUTURED ALONG THE ANNULUS OF THE POSTERIOR LEAFLET. LEAFLET AUGMENTATION WAS PERFORMED AFTER THE INITIAL ANNULOPLASTY ATTEMPT, AND NO ALLEGATIONS WERE MADE AGAINST THE ANNULOPLASTY BAND ITSELF. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Mitral Regurgitation

    MAUDE report 10636460 ↗

Other RING, ANNULOPLASTY devices

All RING, ANNULOPLASTY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.