Chocolate® CB1812060080OTW (UDI 00763000430573)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000430573), received between Nov 20, 2023 and Aug 7, 2024 — classified as 2 malfunctions.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2024Difficult to Remove; Difficult to Remove

  A CHOCOLATE PTA BALLOON WAS BEING USED FOR TREATMENT OF A CALCIFIED LESION WITH 60% STENOSIS IN THE DISTAL REGION OF THE COMMON ILIAC ARTERY. A NON MEDTRONIC INFLATION DEVICE WAS USED. THE CHOCOLATE BALLOON WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE WHILE ADVACING THE DEVICE AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. AFTER THE STANDARDIZED SURGICAL OPERATION, THE 18-WIRE GUIDE PASSED THROUGH THE LESION. THE LESION WAS NOT SHORT SEGMENT NARROWED, AND A CHOCOLATE BALLOON WAS SELECTED FOR DIRECT DILATATION. USED A PRESSURE PUMP TO SLOWLY INFLATE THE CHOCOLATE BALLOON. AFTER THREE MINUTES OF DILATATION, THE BALLOON WAS DEFLATED. WHEN IT WAS WITHDRAWN FROM THE BODY, IT CAME INTO CONTACT WITH THE 6F SHEATH AND COULD NOT BE WITHDRAWN SMOOTHLY. IT WAS SLIGHTLY INFLATED AND DEFLATED AGAIN IN THE BODY. AFTER REPEATED IT TWICE, IT WAS WITHDRAWN FROM THE BODY WITH DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928962 ↗
• MalfunctionNov 20, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CHOCOLATE BALLOON TO TREAT A CALCIFIED LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS MODERATE. LESION STENOSIS WAS 60%. EMBOLIC PROTECTION WAS NOT USED. BALLOON WAS INFLATED WITH A MERIT DEVICE. DEVICE WAS PREPPED PER IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THERE WAS BALLOON DEFLATION DIFFICULTIES. DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE. AFTER DISCOVERING A PROBLEM WITH THE BALLOON, INFLATED THE BALLOON AGAIN AND DEPLOYED THE PRESSURE AGAIN, THEN SLOWLY HUGGED THE BALLOON BACK AND WITHDREW IT FROM THE BODY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED BY REPLACING IT WITH AN ORDINARY BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170050 ↗