Chocolate™ CB1413535040OTWRecalls & reported problems
Medtronic, Inc. · PTA CB1413535040 CHOCOLATE 014 V05 · 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 00763000500061), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
- Difficult to Remove1
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.
MalfunctionSep 29, 2026Difficult to Insert; Difficult to Remove
It was reported that during treatment of a 90% stenotic, 30 mm plaque lesion in the mid right tibial/popliteal trunk peripheral artery, with minimal tortuosity and a 4 mm vessel diameter, a 3.5 x 40 Chocolate .014 percutaneous transluminal angioplasty balloon catheter was used through a 6F Destination sheath. The vessel was pre-dilated with a 3 x 80 Nanocross percutaneous transluminal angioplasty balloon catheter, and the lesion remained visible on fluoroscopy. After the Chocolate balloon catheter was opened, inspected, and flushed, resistance was felt when backloading a .014 Command guidewire through the catheter. The guidewire was removed, a new .014 Command ES guidewire was opened, and the Chocolate catheter was re-flushed and backloaded without issue. The Chocolate catheter was tracked through the lesion and inflated without issue using 50/50 contrast. The catheter was removed for follow-up DSA imaging, and the lesion remained visible. Extreme resistance was encountered when reloading the Chocolate catheter over the .014 Command guidewire. Difficulty removing the Chocolate catheter and flushing the balloon catheter lumen were reported. The Chocolate catheter and gui dewire were
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929054 ↗
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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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