Duran AnCore™ 620RG33Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169793415), received between Jul 12, 2021 and Dec 4, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 3 YEARS POST IMPLANT OF THIS 33MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND R EPLACED WITH A 33MM MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18262948 ↗
• InjuryOct 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 8 MONTHS POST IMPLANT OF THIS 33MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 30MM 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 17951068 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 33MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 3 7MM MITRAL ANNULOPLASTY BAND DUE TO SYSTOLIC ANTERIOR MOTION AND SIGNIFICANT MITRAL REGURGITATION BEING OBSERVED. IT WAS REPORTED THAT THE PATIENT HAD A RUPTURED CHORDAE TO THE P2 SEGMENT OF THE POSTERIOR LEAFLET AND THAT THE ANNULUS WAS DILATED. NO ADDITIONAL ADV ERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15895919 ↗
• InjuryOct 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 33MM MITRAL ANNULOPLASTY RING,  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 12673932 ↗
• InjuryJul 12, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT THIS 33MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND THEN IMMEDIATELY EXPLANTED. IT WAS REPLACED WITH A 31MM RING OF THE SAME MODEL. THE REASON FOR THE SIZE CHANGE WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12150142 ↗