Duran AnCore® 620RG29 (UDI 00721902859793)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00721902859793), received between Jan 30, 2019 and Feb 18, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR (AV) BLOCK AND ATRIAL ARRHYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION AND ATRIAL FLUTTER). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 21404370 ↗
• InjuryFeb 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR (AV) BLOCK AND ATRIAL ARRHYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION AND ATRIAL FLUTTER). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 21381263 ↗
• InjuryJul 5, 2023Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 5 MONTHS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 28MM MITRAL MECHANICAL VALVE. 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 17257761 ↗
• InjuryJun 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY RING IMPLANTED IN THE AORTIC POSITION AT THE SUTURE LINE OF A 20MM UNKNOWN HOMOGRAFT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEMODYNAMICALLY COMPROMISING ATRIAL FIBRILLATION THAT WAS CONVERTED WITH INTRAVENOUS AMIODARON, THEN ORAL AMIODARONE. MEDICATION WAS DISCONTINUED AFTER ONE WEEK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 17162224 ↗
• InjuryOct 15, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 1 MONTH POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC MECHANICAL VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE MITRAL STENOSIS. IT WAS ALSO NOTED THERE WAS PANNUS OVERGROWTH ON THE PATIENT'S NATIVE MITRAL VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Host-Tissue Reaction; Mitral Valve Stenosis

  MAUDE report 9192103 ↗
• InjuryJan 30, 2019Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS 3 MONTHS POSTS IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Corneal Pannus; Ischemia; Mitral Valve Stenosis; No Information

  MAUDE report 8289203 ↗