Duran AnCore® 620RG25 (UDI 00721902859762)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00721902859762), received between Mar 24, 2017 and Jan 8, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

• InjuryJan 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 6 MONTHS POST IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY RING, A BI-VENTRICULAR DEFIB RILLATOR WAS IMPLANTED. THE REASON FOR THE BI-VENTRICULAR DEFIBRILLATOR WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21100120 ↗
• InjuryJan 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 2ND DEGREE ATRIOVENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21095177 ↗
• InjuryJun 7, 2024Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS AND 3 MONTHS POST IMPLANT OF THIS 25MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 19492548 ↗
• InjurySep 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 6 MONTHS POST IMPLANT OF THIS 25MM ANNULOPLASTY RING IMPLANTED IN THE MITRAL POSITION, THE PATIENT PRESENTED WITH NEW YORK HEART ASSOCIATION (NYHA) CLASS III SYMPTOMS (DYSPNEA AND EXERCISE INTOLERANCE) AS WELL AS LOWER EXTREMITY SWELLING AND DIFFICULT TO CONTROL PRE-EXISTING ATRIAL FIBRILLATION (AFIB). TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED MITRAL REGURGITATION AND MODERATE STENOSIS. THE PATIENT SUBSEQUENTLY UNDERWENT RIGHT AND LEFT HEART CATHETERIZATION AT AN UNKNOWN TIME POST IMPLANT. ULTIMATELY, 10 YEARS AND 7 MONTHS POST IMPLANT OF THE ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. DURING PLACEMENT OF THE MITRAL VALVE, THE NATIVE ANTERIOR LEAFLET WAS BISECTED AND BROUGHT TO THE 4 AND 8 O'CLOCK POSITION. THE ENTIRE POSTERIOR LEAFLET AND VALVULAR STRUCTURES WERE RETAINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.  ADDITIONAL INFORMATION WAS RECEIVED THAT IMMEDIATELY AFTER IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, TEE CONFIRMED MODERATE REGURGITATION. NO INTERVENTIONS OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Dyspnea; Mitral Regurgitation; Mitral Valve Stenosis

  MAUDE report 7889228 ↗
• InjuryMar 24, 2017Gradient Increase; Adverse Event Without Identified Device or Use Problem; Gradient Increase; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY NINE YEARS POST IMPLANT OF THIS ANNULOPLASTY RING, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE DUE TO STENOSIS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 6431914 ↗