Duran AnCore® 620RG35 (UDI 00721902859823)Recalls & reported problems
Medtronic, Inc. · RING 620RG35 ANLO DURAN ANCORE CHORD 10L · Class 2 · Implant
All models of Duran AnCore (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00721902859823), received between May 10, 2021 and Dec 8, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information2
- Mitral Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 6 MONTHS POST IMPLANT OF THIS 35MM TRICUSPID ANNULOPLASTY RING, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 20875539 ↗InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 4 MONTHS POST IMPLANT OF THIS 35MM 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; Mitral Valve Insufficiency/ Regurgitation
MAUDE report 11798985 ↗
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- CG FUTURE™ 638BL28Medtronic, Inc. · RING, ANNULOPLASTY1 death47 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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