Chocolate® CB1415030040OTW (UDI 00763000240387)Recalls & reported problems
Medtronic, Inc. · PTA CB1415030040 CHOCOLATE 014 V02 · 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 00763000240387), received between Nov 3, 2020 and Nov 3, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionNov 3, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
PHYSICIAN INTENDED TO USE A CHOCOLATE PTA BALLOON WITH A NON-MEDTRONIC INFLATION DEVICE DURING TREATMENT OF A 170MM CALCIFIED LESION IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 95% STENOSIS. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS REPORTED WHEN ADVANCING THE DEVICE, BUT NO EXCESSIVE FORCE WAS USED. IT IS REPORTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT THAT THE CAGE HAD DISLODGED AND MIGRATED DISTALLY (FORWARD) ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DRUG COATED BALLOON. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10777089 ↗
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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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