Chocolate® CB1415030040OTW (UDI 00763000430504)Recalls & reported problems
Medtronic, Inc. · PTA CB1415030040 CHOCOLATE 014 V04 · Class 2
All models of Chocolate (17)
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 00763000430504), received between May 2, 2023 and May 2, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Material Deformation1
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.
MalfunctionMay 2, 2023Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
A PHYSICIAN WAS USING A CHOCOLATE PTA BALLOON FOR THE TREATMENT OF A PLAQUE SOFT TISSUE LESION IN THE MID RIGHT ANTERIOR TIBIAL ARTERY. THERE WAS NO TORTUOSITY OR CALCIFICATION. A 6FR NON MEDTRONIC SHEATH AND A 0.014 NON MEDTRONIC GUIDEWIRE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE BALLOON WAS INFLATED TO NOMINAL WITH A SLOW INFLATION. NO RESISTANCE NOTED DURING ADVANCEMENT. WHEN COMING DOWN WITH BALLOON THEY HAD DIFFICULTY PULLING CATHETER OUT IN VESSEL. CAGE ON THE CHOCOLATE BALLOON WAS DAMAGED AFTER SINGLE INFLATION, THE CAGE DETACHED PARTIALLY OFF THE BALLOON IN THE VESSEL. BREAK/FACTURE OCCURRED AT THE TIP/BALLOON, REMOVED WITHIN SHEATH AND NO DETACHED PORTION REMAINS IN THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY REPORTED FOR THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16853399 ↗
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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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