Chocolate® CB1812060080OTW (UDI 00763000240455)Recalls & reported problems
Medtronic, Inc. · PTA CB1812060080 CHOCOLATE 018 V02 · Class 2
All models of Chocolate (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000240455), received between Jul 1, 2020 and Jul 1, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2020Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN WAS ATTEMPTING TO USE A CHOCOLATE PTA BALLOON ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.014 GUIDE WIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 70% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH WERE 6MM AND 80MM RESPECTIVELY. THERE WAS NO DAMAGED NOTED TO DEVICE PACKAGING. THERE WERE NO ISSUES IDENTIFIED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUE IDENTIFIED. IT WAS REPORTED THAT DURING FIRST INFLATION A RADIAL BURST OCCURRED AT 12ATM. THE DEVICE PASSED THROUGH A PREVIOUSLY IMPLANTED STENT. ALL BALLOON FRAGMENTS WERE RETRIEVED. THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING DEVICE. THE PROCEDURE WAS COMPLETED BY PUTTING PRESSURE ON THE GROIN. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10217478 ↗
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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 13, 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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