Duran AnCore™ 620RG27Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169793385), received between Mar 12, 2020 and Jul 9, 2026 — 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. How this data works · Data updated Oct 13, 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.

• InjuryJul 9, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 27MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS RESIDUAL MITRAL REGURGITATION. IT WAS NOTED THAT THE ANNULOPLASTY PRODUCT DID NOT MALFUNCTION AND THAT THE ANNULOPLASTY PRODUCT WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. IT WAS REPORTED THAT THE PATIENT DID HAVE PRE-EXISTING CONDITIONS/ANATOMICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 25760542 ↗
• InjuryJul 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM RING OF THE SAME MAKE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WEREREPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17343678 ↗
• InjuryDec 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12934498 ↗
• InjuryNov 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM MITRAL ANNULOPLASTY RING, 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

  MAUDE report 10885399 ↗
• InjuryMar 12, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM ANNULOPLASTY RING, IT WAS INCORRECTLY SIZED AND WAS REPLACED WITH THE SAME MODEL 25MM RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9824500 ↗