Chocolate® CB1812060120OTWRecalls & reported problems
Medtronic, Inc. · PTA CB1812060120 CHOCOLATE 018 V04 · 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 00763000430580), received between Jul 25, 2022 and Jul 25, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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.
Most reported problems
Device problems
- 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.
MalfunctionJul 25, 2022Material Deformation; Material Deformation
PHYSICAL ATTEMPTED TO USE A CHOCOLATE PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 100MM CALCIFIED LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY. NO VESSEL TORTUOSITY AND LITTLE CALCIFICATION ARE REPORTED. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A CONTRAST/SALINE MIXTURE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND NO EXCESSIVE FORCE WAS USED. IT IS REPORTED THE CHOCOLATE BALLOON WAS TAKEN OUT AFTER DILATION TREATMENT, AND IT WAS FOUND THAT THE NICKEL-TITANIUM METALLIC WIRE ON THE SURFACE OF THE BALLOON WAS BROKEN. THE BROKEN NICKEL-TITANIUM METALLIC WIRE REMAINED ATTACHED. NO INTERVENTION REQUIRED TO REMOVE BROKEN NICKEL-TITANIUM METALLIC WIRE AND IT WAS REMOVED FROM THE VESSEL ALONG WITH THE BALLOON. THE DEVICE WAS SAFE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15091440 ↗
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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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