Chocolate® PTA Balloon Catheter CB1812060120OTWRecalls & reported problems
Medtronic, Inc. · PTA CB1812060120 CHOCOLATE 018 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000115272), received between Jun 28, 2019 and Jun 28, 2019 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN INTENDED TO USE A CHOCOLATE PTA BALLOON WITH A NON-MEDTRONIC 7FR SHEATH AND GUIDEWIRE DURING TREATMENT OF A 200MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S PROXIMAL, MID AND DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. ATHERECTOMY (TURBOHAWK) HAD BEEN PERFORMED PRIOR TO THIS. VESSEL DIAMETER REPORTED AS 6MM. THE LESION IS DESCRIBED AS BEING CALCIFIED AND FIBROUS. MODERATE TORTUOSITY AND CALCIFICATION ARE REPORTED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE BALLOON WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS EXPERIENCED. AN ANGIOGRAM WAS DONE POST USE OF THE BALLOON AND THE PHYSICIAN OBSERVED THE CAGING OF THE CHOCOLATE BALLOON HAD COME OFF. THE PHYSICIAN TRAPPED THE CAGING TO THE POPLITEAL WALL. TREATMENT CONFIRMED WITH A 5.5X150X120 DEVICE TO COMPLETE THE PROCEDURE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8744281 ↗
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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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