Duran AnCore® 620BG33 (UDI 00613994749741)Recalls & reported problems
Medtronic, Inc. · BAND 620BG33 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 00613994749741), received between Aug 9, 2017 and Aug 9, 2017 — classified as 1 injury.
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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT AN UNKNOWN DURATION POST IMPLANT OF THIS ANNULOPLASTY RING, THE DEVICE WAS EXPLANTED AND REPLACED WITH AN UNKNOWN NON-MEDTRONIC PRODUCT. THE PATIENT WAS LOST TO FOLLOW-UP WITH HER PREVIOUS IMPLANTING PHYSICIAN. THERE IS NO INDICATION WHERE, WHY, OR WHEN THIS REPLACEMENT PROCEDURE OCCURRED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 6777434 ↗
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- CG FUTURE™ 638BL30Medtronic, Inc. · RING, ANNULOPLASTY1 death65 reports
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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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