Chocolate® CB1415025120OTW (UDI 00763000336707)Recalls & reported problems
Ev3, Inc · PTA CB1415025120 CHOCOLATE 014 V03 · Class 2
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 00763000336707), received between Apr 29, 2022 and Apr 29, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN USED A CHOCOLATE PTA BALLOON DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT'S PROXIMAL POSTERIOR TIBIAL ARTERY. MODERATE VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 60% STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED A BREAK/FRACTURE OCCURRED ON THE TIP OF THE DEVICE DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. THE DETACHED TIP WAS REMOVED WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BRAND DEVICE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14249592 ↗
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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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