Duran AnCore® 620BG29 (UDI 00613994749765)Recalls & reported problems
Medtronic, Inc. · BAND 620BG29 DURAN ANCORE 10L INSERT · Class 2
All models of Duran AnCore (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994749765), received between Jun 12, 2025 and Jun 12, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Non specific EKG/ECG Changes1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 4 MONTHS POST IMPLANT OF THIS 29MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 22197600 ↗
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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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