Chocolate™ CB1413540120OTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000500115), received between Jul 28, 2025 and Nov 24, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Device Difficult to Setup or Prepare; Difficult to Remove; Difficult to Advance; Positioning Problem; Device Difficult to Setup or Prepare; Difficult to Remove; Difficult to Advance; Positioning Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A CHOCOLATE BALLOON TO TREAT A PLAQUE LESION IN THE SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY MODERATE. DEGREE OF CALCIFICATION MODERATE. BALLOON WAS INFLATED WITH A BOSTON SCIENTIFIC PRESSURE PUMP. THERE WERE WIRE MOVEMENT ISSUES. DIFFICULTIES LOADING OR EXCHANGING GUIDEWIRE. POOR GUIDEWIRE MOVEMENT DURING PROCEDURE. DIFFICULTY REMOVING BALLOON PRIOR TO BALLOON INFLATION. RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE SURGERY WAS COMPLETED AFTER REPLACING THE BALLOON WITH ONE OF THE SAME SIZE CHOCOLATE BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631181 ↗
• InjuryOct 23, 2025Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE CHOCOLATE BALLOON, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE THROUGH A SEVERELY CALCIFIED LESION (90% STENOSIS) LOCATED IN THE MID AND DISTAL SEGMENTS OF THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. THE ARTERY WAS MILDLY TORTUOUS. THE METAL WIRE OF THE CHOCOLATE BALLOON DETACHED AND COULD NOT BE REMOVED, A STENT WAS USED TO SECURE AND ATTACH THE RETAINED DEVICE COMPONENT WITHIN THE VESSEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23366653 ↗
• InjurySep 5, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT SEVERE (90%) STENOSIS AND CALCIFICATION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY NEAR THE POPLITEAL FOSSA P1 SEGMENT, THERE WERE BALLOON INFLATION DIFFICULTIES AND THE CHOCOLATE BALLOON WOULD NOT OPEN. THE ARTERY WAS 4.5MM IN DIAMETER. THERE WAS MILD TORTUOSITY. ANGIOGRAPHY REVEALED SEVERE STENOSIS AND CALCIFICATION PRIOR TO INTERVENTION. PRE-DILATATION WAS PERFORMED WITH A 2.5X120 NON MEDTRONIC BALLOON. WHEN A 4X120 CHOCOLATE BALLOON WAS USED FOR FURTHER DILATATION, INFLATION WAS ATTEMPTED AT 12 ATM USING A PRESSURE PUMP, BUT THE BALLOON WAS DIFFICULT TO INFLATE AND DID NOT OPEN, SO IT WAS REMOVED. SUBSEQUENT DILATATION WITH A 4X120 NON MEDTRONIC BALLOON REVEALED A FLOW-LIMITING DISSECTION. A NON MEDTRONIC STENT WAS THEN INSERTED, RESTORING BLOOD FLOW AND COMPLETING THE PROCEDURE. IT IS UNCERTAIN IF THERE IS A LEAK AND IT IS UNCERTAIN WHAT THE CAUSE OF THE DISSECTION WAS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 22975622 ↗
• MalfunctionJul 28, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE CHOCOLATE BALLOON, THE BALLOON WAS POORLY INFLATED AND COULD NOT FULLY DILATE THE LESION IN THE MID POPLITEAL ARTERY. A BALLOON BURST OR LEAK WAS OBSERVED DURING BALLOON INFLATION AT 4ATM. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH ANOTHER OF THE SAME BRAND AND MODEL TO DILATE THE LESION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630681 ↗