Chocolate® CB1413540120OTW (UDI 00763000430467)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000430467), received between Aug 30, 2023 and Feb 20, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (4 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.

• MalfunctionFeb 20, 2025Deflation Problem; Difficult to Advance; Deflation Problem; Difficult to Advance

  A CHOCOLATE PTA BALLOON WAS BEING USED FOR TREATMENT OF A CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. THERE WAS MILD TORTUOSITY AND MODERATE CALCIFICATION. A NON MEDTRONIC INFLATION DEVICE WAS USED. IT WAS REPORTED THE POPLITEAL ARTERY SEGMENT WAS OCCLUDED. AFTER ESTABLISHING THE INTERVENTIONAL CHANNEL, A 4*120 CHOCOLATE BALLOON WAS TRIED TO PASS THROUGH THE LESION AND INFLATE TO THE STANDARD PRESSURE. RESISTANCE WAS MED DURING ADVANCEMENT TO THE LESION. AFTER 3 MINUTES OF INFLATION, THE BALLOON HAD DIFFICULTY IN DEFLATING AFTER THE PRESSURE PUMP REDUCED THE PRESSURE. THE BALLOON WAS INFLATED AGAIN AND NEGATIVE PRESSURE WAS APPLIED. AFTER SEVERAL ATTEMPTS, THE BALLOON WAS SUCCESSFULLY DEFLATED AND WAS WITHDRAWN FROM THE BODY. BALLOON TOOK MORE THAN 5 SECONDS TO DEFLATE. ANOTHER BALLOON WAS USED TO CONTINUE TO DILATE THE SUPERFICIAL FEMORAL ARTERY, AND A DRUG COATED BALLOON WAS APPLIED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419170 ↗
• MalfunctionFeb 11, 2025Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A CHOCOLATE PTA BALLOON DILATATION DEVICE TO TREAT THE LEFT MID POPLITEAL ARTERY OF A PATIENT REPORTED TO BE FIBROUS, CALCIFIED AND WITH TORTUOSITY AND PLAQUE WITH 85% STENOSIS. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. DEVICE WAS PREPARED AND FOLLOWED AS PER IFU. 6F SHEATH WAS USED AND A C14 GUIDEWIRE USED, AND AN INFLATION DEVICE (PRESSURE PUMP) WAS USED. DEVICE WAS PREPPED AND USED AS PER IFU. IT WAS REPORTED BALLOON DEFLATION DIFFICULTIES OCCURRED, DEVICE SLOW TO DEFLATE AT THE LESION SITE. THE NICKEL-TITANIUM WIRE DETACHED/PROLAPSED FROM THE BALLOON DURING THE PROCESS OF THE BALLOON BEING WITHDRAWN FROM THE BODY. THE SEPARATED PART WAS NOT DETACHED FROM THE BALLOON BUT WAS WITHDRAWN FROM THE BODY ALONG WITH THE BALLOON. NO EXCESSIVE FORCE WAS USED. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356103 ↗
• MalfunctionJan 13, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A CHOCOLATE BALLOON DILATATION DEVICE FOR TREATMENT IN A PATIENT IN THE RIGHT MID POPLITEAL ARTERY WITH PLAQUE, MODERATE PLAQUE, CALCIFICATION AND 100% STENOSIS (CTO). NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IFU WAS FOLLOWED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE NOTED. DEVICE SLOW TO DEFLATE AT THE LESION SITE AND DEFLATION TIME WAS 30 SECONDS. CHOCOLATE BALLOON WAS REPLACED WITH ANOTHER THE OTHER BALLOON TO COMPLETE THE SURGERY. NO INJURY TO PATIENT REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137823 ↗
• MalfunctionJun 27, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CHOCOLATE BALLOON TO TREAT A CALCIFIED PLAQUE LESION IN THE MID POPLITEAL ARTERY. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS MODERATE. LESION STENOSIS WAS 80%. EMBOLIC PROTECTION WAS NOT USED. THE BALLOON WAS INFLATED WITH A BALLOON. 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 DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION, REPEATED PULLING WAS REQUIRED BECAUSE THE GUIDE WIRE CAUGHT ON THE BALLOON. THERE WAS NO VESSEL DAMAGE AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. PROCEDURE COMPLETED BY REPLACING THE BALLOON. NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE BALLOON WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622797 ↗
• MalfunctionAug 30, 2023Deflation Problem; Deflation Problem

  A PHYSICIAN WAS ATTEMPTING TO USE A CHOCOLATE PTA BALLOON FOR TREATMENT OF A CALCIFIED LESION WITH 80% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY. THERE WAS SEVERE CALCIFICATION AND NO TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU. NO DAMAGE WAS NOTED TO THE BALLOON CATHETER. PRESSURE PUMP INJECTION INFLATION WAS USED TO INFLATE THE BALLOON. NO ISSUES NOTED DURING INFLATION OF THE BALLOON. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS MET DURING ADVANCEMENT. IT WAS REPORTED THAT THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE. THE BALLOON WAS REMOVED AFTER PARTIAL DEFLATION, A PRESSURE PUMP WAS USED TO DEFLATE. AFTER REMOVAL, IT WAS REPLACED AND NORMAL BALLOON DILATION COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649530 ↗