Duran AnCore® 620BG27 (UDI 00613994749772)Recalls & reported problems
Medtronic, Inc. · BAND 620BG27 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 00613994749772), received between Feb 8, 2017 and Feb 8, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
Patient problems
- Chest Pain1
- Dyspnea1
- Swelling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 5 MONTHS POST IMPLANT OF THIS ANNULOPLASTY BAND, THE PATIENT PRESENTED WITH COMPLAINTS OF ORTHOPNEA, SHORTNESS OF BREATH ON EXERTION, CHEST PAIN, AND LEG SWELLING. THE DEVICE WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE DUE TO MITRAL STENOSIS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Chest Pain; Dyspnea; Swelling
MAUDE report 6313082 ↗
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- Tri-Ad™ 900SFC228Medtronic, Inc. · RING, ANNULOPLASTY4 deaths56 reports
- CG FUTURE™ 638BL34Medtronic, Inc. · RING, ANNULOPLASTY51 reports
- Contour 3D® 690R30Medtronic, Inc. · RING, ANNULOPLASTY1 death50 reports
- 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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