Chocolate® CB1812050120OTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000430559), received between Sep 5, 2022 and Jan 8, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A CHOCOLATE 018 BALLOON DILATATION DEVICE TO TREAT A PATIENT IN THE MID SUPERFICIAL FEMORAL ARTERY WITH CALCIFICATION, FIBROUS AND TORTUOSITY AND 80% STENOSIS. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IFU WAS FOLLOWED. A NON-MEDTRONIC SHEATH (6F DESTINATION 45 CM) AND A NON-MEDTRONIC GUIDEWIRE (GLIDEWIRE ADVANTAGE .035 260 CM). IFU WAS FOLLOWED. IT WAS REPORTED THAT A LONGITUDINAL BALLOON BURST OCCURRED, DURING BALLOON INFLATION. AFTER THE 35 GUIDEWIRES PASSED THROUGH THE SUPERFICIAL FEMORAL ARTERY, AN EVERCROSS BALLOON 3*150 WAS USED TO DILATE THE LESION. THEN CHANGED TO A V18 GUIDEWIRE AND A CHOCOLATE BALLOON WAS USED TO DILATE THE LESION. FIRST, INFLATED TO 3 ATM, AND THEN DURING INFLATING TO 7 ATM, THE BALLOON BURST.THE BALLOON WAS REPLACED WITH AN 18 BALLOON FROM ANOTHER MANUFACTURER FOR DILATION AND THE OPERATION WAS COMPLETED WITH A DRUG-COATED BALLOON. NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102168 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN WAS USING A CHOCOLATE BALLOON FOR TREATMENT DURING DILATION OF THE LOWER RIGHT LIMB FEMORAL ARTERY DUE TO RIGHT LOWER LIMB ISCHEMIA. AFTER DILATATION, THROMBOSIS WAS FOUND IN THE SUPERFICIAL FEMORAL ARTERY, AND THE THROMBOSIS COULD NO LONGER BE ATTACHED TO THE WALL THROUGH THE BALLOON, AND BLOOD FLOW IN THE RIGHT LOWER LIMB COULD NOT BE OPENED. THE DILATATION CATHETER WAS REMOVED AND THE PROCEDURE ENDED. THE PATIENT WAS GIVEN ANTICOAGULATION TREATMENT. THE PATIENT STILL HAD SYMPTOMS OF RIGHT LOWER LIMB ARTERY ISCHEMIA.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 20878851 ↗
• MalfunctionDec 2, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE THERE WAS DIFFICULTY REMOVING A CHOCOLATE 018 BALLOON FROM THE BODY FOLLOWING BALLOON INFLATION. THE PROCEDURE INVOLVED THE SUPERFICIAL FEMORAL ARTERY, SPECIFICALLY AT A DISTAL LOCATION WITH A CALCIFIED TARGET LESION EXHIBITING LITTLE TORTUOSITY, MODERATE CALCIFICATION AND 60% STENOSIS. A PRESSURE PUMP WAS USED FOR BALLOON INFLATION. DESPITE SEVERAL ATTEMPTS, THE BALLOON COULD NOT BE SUCCESSFULLY REMOVED AND WAS EVENTUALLY EXTRACTED TOGETHER WITH THE SHEATH. THE PROCEDURE WAS COMPLETED BY REPLACING THE VASCULAR SHEATH AND CONTINUING WITH THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817554 ↗
• MalfunctionDec 19, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CHOCOLATE BALLOON TO TREAT A PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS NONE. DEGREE OF CALCIFICATION WAS MODERATE. LESION STENOSIS WAS 80%. EMBOLIC PROTECTION WAS NOT USED. 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. THE CONSTRAINT WIRE WAS BROKEN DURING BALLOON EXPANSION. WIRE DID NOT DETACH. IT WAS TAKEN OUT WITH THE BALLOON. PROCEDURE WAS COMPLETED BY USING ANOTHER BALLOON. NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETURNED TO THE FACILITY FOR EVALUATION, IT WAS NOTED THAT THE NITINOL CAGE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18353840 ↗
• MalfunctionSep 5, 2022Difficult to Remove; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE A CHOCOLATE PTA BALLOON DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 60% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. NO EMBOLIC PROTECTION WAS USED. A SYRINGE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT FOLLOWING BALLOON INFLATION, REMOVAL DIFFICULTIES WAS ENCOUNTERED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. AFTER THE BALLOON WAS INFLATED, THE VASODILATION WAS COMPLETED, AND THE RESISTANCE PROBLEM WAS ENCOUNTERED AFTER WITHDRAWAL. REMOVED FROM THE PATIENT AFTER MULTIPLE ATTEMPTS. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO VESSEL DAMAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15355045 ↗