Chocolate™ CB1415025120OTWRecalls & reported problems
Medtronic, Inc. · PTA CB1415025120 CHOCOLATE 014 V05 · 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 00763000500146), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.
Reports received per month
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- 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.
MalfunctionMar 30, 2026Deformation Due to Compressive Stress; Material Deformation
IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID TO DISTAL PERONEAL ARTERY USING A CHOCOLATE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER, THE CATHETER/DELIVERY SYSTEM WAS DEFORMED AND KINKED. MODERATE VESSEL TORTUOSITY AND CALCIFICATION WERE REPORTED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED. NO EMBOLIC PROTECTION WAS USED, AND THE BALLOON WAS INFLATED WITH A SYRINGE. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING OR HOOP/TRAY, AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE CHOCOLATE BALLOON CATHETER WAS REPEATEDLY INFLATED THREE TIMES, AND UPON REMOVAL, A CATHETER FRACTURE (KINK) WAS DISCOVERED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE WAS DAMAGE TO THE NITINOL CAGE. A CATHETER FRACTURE WAS REPORTED BUT REMAINED ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24730254 ↗
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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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