Chocolate® PTA Balloon Catheter CB1812060040OTWRecalls & reported problems
Medtronic, Inc. · PTA CB1812060040 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 00763000115258), received between Oct 16, 2020 and Oct 16, 2020 — 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
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
InjuryOct 16, 2020Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE A CHOCOLATE PTA BALLOON ALONG WITH NON-MEDTRONIC 5/6FR SHEATH AND 0.018" GUIDE WIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 240MM RESPECTIVELY. THE VESSEL WAS MODERATELY TORTUOUS. A NON-MEDTRONIC INDEFLATOR WAS USED FOR BALLOON INFLATION. A 50/50 CONTRAST WAS USED FOR INFLATION FLUID. THERE WAS NO DAMAGE TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. BALLOON FRACTURE OCCURRED WHEN PULLING BALLOON BACK THROUGH VISIPRO STENT. THE DETACHED PORTION OF DEVICE REMAINS IN PATIENT. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING DEVICE. EXCESSIVE FORCE WAS USED DURING WITHDRAWAL. THE CHOCOLATE BALLOON CAGE CAME OFF BALLOON INSIDE STENT IN PATIENT. IT WAS REPORTED THAT THE CAGE SEPARATED FROM BALLOON. PHYSICIAN WAS INFLATING INSIDE STENT TO IRON OUT. PHYSICIAN WAS TOLD NOT TO INFLATE IN A NEWLY DEPLOYED STENT. THE PATIENT WAS MOVED TO THE OPERATING ROOM, WHERE THE P
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10689643 ↗
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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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