Chocolate® PTA Balloon Catheter CB1413540080OTWRecalls & reported problems
Medtronic, Inc. · PTA CB1413540080 CHOCOLATE 014 · Class 2
Data updated Oct 18, 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 00763000115142), received between Mar 22, 2019 and Mar 22, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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 18, 2026.
Most reported problems
Device problems
- Entrapment of Device1
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.
MalfunctionMar 22, 2019Entrapment of Device; Entrapment of Device
THE PHYSICIAN WAS INTENDING TO USE A CHOCOLATE BALLOON TO TREAT A 130MM MODERATELY CALCIFIED PLAQUE LESION WITH 75% STENOSIS IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. SEVERE TORTUOSITY WAS REPORTED IN THE 6MM DIAMETER ARTERY AND JOINT REPLACEMENT WITH LEG FROGGED OUT IN LATERAL POSITION WAS REPORTED IN RELATION TO PATIENT¿S ANATOMY. A NON MEDTRONIC 6FR SHEATH AND A NON MEDTRONIC 0.014 GUIDEWIRE WAS USED IN THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. ACCESS WAS MAINTAINED THROUGH THE STENT AND THE 0.35 GUIDEWIRE AND CHOCOLATE BALLOON WERE ADVANCED THROUGH THE PREVIOUSLY DEPLOYED STENT. THE CHOCOLATE DEVICE WAS INFLATED USING A BARD INFLATION DEVICE WITH CONTRAST/SALINE AND WAS USED TO BALLOON THE EXISTING STENT. AN EVERFLEX STENT WAS PLACED INSIDE THE FIRST STENT TO OPEN THE VESSEL. IT WAS REPORTED THAT THE CHOCOLATE BALLOON CAUGHT ON THE END OF THE EVERF
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8443258 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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