Chocolate® PTA Balloon Catheter CB1413540120OTWRecalls & reported problems
Medtronic, Inc. · PTA CB1413540120 CHOCOLATE 014 · 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 00763000115159), received between Jul 2, 2020 and Jul 2, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- 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.
InjuryJul 2, 2020Deflation Problem; Fracture; Detachment of Device or Device Component; Deflation Problem; Fracture; Detachment of Device or Device Component
THE PHYSICIAN ATTEMPTED TO USE A CHOCOLATE PTA BALLOON TO TREAT THE LEFT PROXIMAL AV GRAFT - VENOUS DISTAL TO ANASTOMOSIS. THERE WAS NO TORTUOSITY OR CALCIFICATION, WITH 20% LESION STENOSIS REPORTED. THE ARTERY WAS 4MM IN DIAMETER AND THE LESION WAS 100MM IN LENGTH. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A 6F NON-MEDTRONIC SHEATH AND NON-MEDTRONIC GUIDEWIRE WERE USED. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE AND 50/50 SALINE/CONTRAST INFLATION FLUID WERE USED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED DURING THE PROCEDURE, THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE. THE DEFLATION ISSUES WERE NOTED FOLLOWING FIRST INFLATION. A BREAK/FRACTURE WAS REPORTED TO HAVE OCCURRED AT CATHETER. THE DETACHED PORTION OF DEVICE DOES NOT REMAIN IN PATIENT AND WAS REMOVED WITH SHEATH AND WIRE. T
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10223707 ↗
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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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