Chocolate™ CB1812050120OTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000500207), received between Oct 31, 2024 and Mar 9, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING A CB1812050120OTW CHOCOLATE PTA BALLOON TO TREAT A PLAQUE LESION WITH 60% STENOSIS IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY, MODERATE TORTUOSITY AND SEVERE CALCIFICATION WERE OBSERVED. A 6F100 NON-MEDTRONIC SHEATH WAS USED. A SYRINGE WAS USED FOR BALLOON INFLATION. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE CHOCOLATE BALLOON WAS USED TO DILATE THE TARGET VESSEL. AFTER THREE INFLATIONS, THE CHOCOLATE BALLOON WAS SAFELY REMOVED FROM THE PATIENT AND ANGIOGRAPHY WAS PERFORMED. SUBSEQUENTLY, THE DEVICE COULD NOT BE ADVANCED INTO THE 6F100 NON-MEDTRONIC SHEATH, AND THE CONSTRAINING WIRE WAS FOUND TO BE SEPARATED. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543065 ↗
• MalfunctionJan 29, 2026Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING A CHOCOLATE BALLOON (5*120), BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE IN THE MID SUPERFICIAL FEMORAL ARTERY, WHICH WAS MODERATELY CALCIFIED AND TORTUOUS. THE CONSTRAINT WIRE OF THE CHOCOLATE BALLOON SEPARATED, AND THE PRODUCT COULD NOT RE-ENTER THE 6F SHEATH. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED, AND NO ABNORMALITIES IN ANATOMY OR PACKAGING WERE NOTED. NO EMBOLIC PROTECTION WAS USED, AND THE BALLOON WAS INFLATED WITH A SYRINGE. THE PATIENT IS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209729 ↗
• MalfunctionJan 19, 2026Fracture; Difficult to Advance

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE CHOCOLATE 018 BALLOON CATHETER FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (100% STENOSIS) WITH SEVERE CALCIFICATION IN THE MID SUPERFICIAL FEMORAL ARTERY, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. WHEN PREPARING FOR A SECONDARY DILATION, THE CONSTRAINING WIRE WAS FOUND TO HAVE FRACTURED; THE FRACTURED WIRE DID NOT DETACH AND WAS REMOVED TOGETHER WITH THE BALLOON CATHETER. THE DEVICE WAS REPLACED WITH ANOTHER BALLOON CATHETER OF THE SAME MODEL, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108949 ↗
• MalfunctionJan 5, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WITH SEVERE STENOSIS OF THE LEFT SUPERFICIAL FEMORAL ARTERY (GREATER THAN 75%) UNDERWENT SEQUENTIAL B ALLOON ANGIOPLASTY USING STANDARD BALLOONS FOLLOWED BY A CHOCOLATE BALLOON. A NON-MEDTRONIC DEVICE WAS USED FOR INFLATION. NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT. DURING RETRIEVAL OF THE CHOCOLATE BALLOON, A METAL WIRE FRACTURE WAS OBSERVED ON THE EXTERIOR OF THE BALLOON. THE PROCEDURE WAS COMPLETED BY REPLACING THE FRACTURED BALLOON WITH A NEW ONE TO CONTINUE DILATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954992 ↗
• MalfunctionDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE CHOCOLATE 018 BALLOON, A PATIENT PRESENTED WITH A CHRONIC TOTAL OCCLUSION (100% LESION STENOSIS) IN THE MID SEGMENT OF THE SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION WAS DESCRIBED AS FIBROUS, WITH MODERATE VESSEL TORTUOSITY AND MODERATE CALCIFICATION. DURING THE PROCEDURE, THE GUIDEWIRE AT THE TIP OF THE DEVICE BROKE. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE, AND NO RESISTANCE OR EXCESSIVE FORCE WAS ENCOUNTERED DURING ADVANCEMENT. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH THE SAME MODEL OF BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887606 ↗
• MalfunctionSep 11, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE CHOCOLATE 018 BALLOON AT THE MID RIGHT SUPERFICIAL FEMORAL ARTERY, THERE WERE BALLOON DEFLATION DIFFICULTIES, INCLUDING THE DEVICE NOT DEFLATING AT THE LESION SITE. DEFLATION ISSUES WERE NOTED FOLLOWING THE FIRST INFLATION AND DURING SUBSEQUENT INFLATION ATTEMPTS. AFTER THE FIRST INFLATION, THE NITINOL WIRE COULD NOT RETURN TO ITS ORIGINAL POSITION CLOSE TO THE BALLOON, MAKING A SECOND INFLATION IMPOSSIBLE. THE TARGET LESION WAS DESCRIBED AS SEVERELY CALCIFIED WITH MODERATE TORTUOSITY AND PLAQUE. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23024652 ↗
• InjuryJun 27, 2025Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY USING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CHOCOLATE BALLOON 018, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE THROUGH A PREVIOUSLY-DEPLOYED STENT. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS OBSERVED THAT THE METAL PART OF THE DEVICE REMAINED ENTIRELY INSIDE THE PATIENT, WITHIN THE STENT, AND IT WAS BELIEVED THAT THE METAL BROKE WHEN PASSING THROUGH THE SHEATH VALVE. THE PROCEDURE WAS COMPLETED BY BALLOONING WITH A CONVENTIONAL BALLOON AND PLACING ANOTHER STENT USING THE "SANDWICH" TECHNIQUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344743 ↗
• MalfunctionJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING A CHOCOLATE BALLOON FOR DILATION OF THE SUPERFICIAL FEMORAL ARTERY, THE NICKEL-TITANIUM WIRE FELL OFF (NITINOL CAGE) DURING WITHDRAWAL OF THE BALLOON. AFTER THE WIRE WAS REMOVED, THE PROCEDURE WAS CONTINUED AND COMPLETED. THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201735 ↗
• MalfunctionMar 13, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A CHOCOLATE BALLOON DILATATION DEVICE IN TREATMENT OF A PATIENT IN THE MID SU PERFICIAL FEMORAL ARTERY WITH PLAQUE CALCIFICATION AND 80% STENOSIS. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT A BALLOON BURST OCCURRED AT 4 ATMS. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER CHOCOLATE BALLOON DEVICE. NO INJURY TO PATIENT REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593944 ↗
• MalfunctionDec 6, 2024Burst Container or Vessel; Difficult to Advance; Burst Container or Vessel; Difficult to Advance

  IT WAS REPORTED THAT A CHOCOLATE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON WAS USED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION WAS CALCIFIED WITH PLAQUE AND HAD A CHRONIC TOTAL OCCLUSION OF 100%. DURING THE PROCEDURE, THE BALLOON BURST LONGITUDINALLY DURING INFLATION. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE INFLATION PRESSURE APPLIED TO THE BALLOON PRIOR TO THE RUPTURE WAS 10 ATMS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED BY REPLACING THE BURST BALLOON WITH ANOTHER BALLOON AND CONTINUING BALLOON DILATATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863611 ↗
• MalfunctionDec 3, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE INVOLVING A CHOCOLATE 018 BALLOON DURING THE ADVANCEMENT OF THE BALLOON INTO THE LESION, DETERIORATION WAS OBSERVED IN THE NITINOL WIRES ON THE BALLOON, AND RESISTANCE WAS ENCOUNTERED. THE BALLOON WAS BROKEN, THERE WAS DAMAGE TO THE WIRES ON IT. THE PROCEDURE WAS CONDUCTED ON A CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY, WHICH EXHIBITED SEVERE TORTUOSITY AND CALCIFICATION, WITH A 95% STENOSIS OVER A LENGTH OF 120 MILLIMETERS. THE ARTERY DIAMETER WAS 5 MILLIMETERS, AND A 6 FRENCH SIZE SHEATH AND GUIDEWIRE WERE USED. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE, AND NO EXCESSIVE FORCE WAS APPLIED. THE FAULTY DEVICE WAS REMOVED AND REPLACED WITH A NEW PACKAGED PRODUCT, ALLOWING THE PROCEDURE TO BE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831395 ↗
• MalfunctionNov 19, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  A CHOCOLATE BALLOON WAS INTENDED TO BE USED FOR TREATMENT OF THE SUPERFICIAL FEMORAL ARTERY. IT WAS REPORTED THE INNER STERILE PACKAGING WAS FOUND TO BE UNSEALED. THIS ISSUE WAS IDENTIFIED PRIOR TO THE USE OF THE DEVICE. THE OUTER PACKAGING WAS INTACT, BUT UPON OPENING, THE INNER PACKAGING WAS COMPROMISED, LEADING TO A BREACH IN STERILITY. AS A RESULT, THE PHYSICIAN OPTED TO USE AN ALTERNATIVE BALLOON TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723757 ↗
• MalfunctionOct 31, 2024Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN ATTEMPTED TO USE A CHOCOLATE 018 PTA BALLOON TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY OF A PATIENT. NO VESSEL TORTUOSITY REPORTED. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. THE BALLOON INFLATED WITH A SYRINGE. IT IS REPORTED THAT A BALLOON BURST OCCURRED AT 8 ATM DURING INFLATION. THE PROCEDURE COMPLETED A NEW BALLOON OF SAME MODEL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578785 ↗