Chocolate™ CB1812060120OTWRecalls & reported problems
Medtronic, Inc. · PTA CB1812060120 CHOCOLATE 018 V05 · Class 2
All models of Chocolate (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000500238), received between May 15, 2024 and Dec 10, 2025 — classified as 1 injury, 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Deflation Problem1
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT A PERIPHERAL/ENDOVENOUS LESION WITH MODERATE CALCIFICATION IN THE MID SUPERFICIAL FEMORAL ARTERY, THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CHOCOLATE 018 BALLOON EXHIBITED DEFLATION DIFFICULTIES. THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE, AND DEFLATION ISSUES WERE NOTED DURING SUBSEQUENT INFLATION. DURING THE FOURTH INFLATION, THE NITINOL CONSTRAINING WIRE FAILED TO RETRACT INTO THE BALLOON. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH A 6-80 CB. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23766954 ↗InjuryMay 15, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
LIMITED INFORMATION REPORTED THAT DURING REMOVAL OF THE CHOCOLATE PTA BALLOON CATHETER AFTER AN ANGIOPLASTY PROCEDURE, THE NITINOL CONTAINING CAGE WAS STRIPPED AND RETAINED WITHIN THE PATIENT WHEN THE CATHETER WAS ENTANGLED WITH THE PREVIOUS STENT¿S STRUTS. THERE WERE NO ATTEMPTS TO REMOVE THE CAGE, THE PHYSICIAN BALLOONED THE CAGE AGAINST THE VESSEL WALL THEN PLACED AN EVERFLEX STENT. THE PREVIOUSLY DEPLOYED STENT IS NOT KNOWN. THERE WAS NO DEFORMATION NOTED TO THE DEPLOYED STENT. THERE WAS NO VESSEL DAMAGE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19320666 ↗
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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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