ChocolateRecalls & reported problems across all models

We found 17 models of Chocolate by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Jul 1, 2020 and Sep 29, 2026 — classified as 6 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Chocolate problems

Chocolate models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Chocolate™ CB1812050120OTW

  Catheter, angioplasty, peripheral, transluminal
  13 reports
• Chocolate® CB1413540120OTW

  Catheter, angioplasty, peripheral, transluminal
  5 reports
• Chocolate® CB1812050120OTW

  Catheter, angioplasty, peripheral, transluminal
  5 reports
• Chocolate™ CB1413540120OTW

  Catheter, angioplasty, peripheral, transluminal
  4 reports
• Chocolate® CB1812060080OTW

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• Chocolate™ CB1812060120OTW

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• Chocolate® CB1415030040OTW

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Chocolate® CB1812060080OTW

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Chocolate® CB1413535120OTW

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Chocolate® CB1415025120OTW

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Chocolate® CB1415030040OTW

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Chocolate® CB1812060120OTW

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Chocolate™ CB1413535040OTW

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Chocolate™ CB1413540080OTW

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Chocolate™ CB1415025120OTW

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Chocolate™ CB1812050040OTW

  Catheter, angioplasty, peripheral, transluminal
  1 report
• Chocolate™ CB1812060080OTW

  Catheter, angioplasty, peripheral, transluminal
  1 report

Recent Chocolate adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Insert; Difficult to Remove

  It was reported that during treatment of a 90% stenotic, 30 mm plaque lesion in the mid right tibial/popliteal trunk peripheral artery, with minimal tortuosity and a 4 mm vessel diameter, a 3.5 x 40 Chocolate .014 percutaneous transluminal angioplasty balloon catheter was used through a 6F Destination sheath. The vessel was pre-dilated with a 3 x 80 Nanocross percutaneous transluminal angioplasty balloon catheter, and the lesion remained visible on fluoroscopy. After the Chocolate balloon catheter was opened, inspected, and flushed, resistance was felt when backloading a .014 Command guidewire through the catheter. The guidewire was removed, a new .014 Command ES guidewire was opened, and the Chocolate catheter was re-flushed and backloaded without issue. The Chocolate catheter was tracked through the lesion and inflated without issue using 50/50 contrast. The catheter was removed for follow-up DSA imaging, and the lesion remained visible. Extreme resistance was encountered when reloading the Chocolate catheter over the .014 Command guidewire. Difficulty removing the Chocolate catheter and flushing the balloon catheter lumen were reported. The Chocolate catheter and gui dewire were

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929054 ↗
• MalfunctionMar 30, 2026Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID TO DISTAL PERONEAL ARTERY USING A CHOCOLATE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER, THE CATHETER/DELIVERY SYSTEM WAS DEFORMED AND KINKED. MODERATE VESSEL TORTUOSITY AND CALCIFICATION WERE REPORTED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED. NO EMBOLIC PROTECTION WAS USED, AND THE BALLOON WAS INFLATED WITH A SYRINGE. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING OR HOOP/TRAY, AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE CHOCOLATE BALLOON CATHETER WAS REPEATEDLY INFLATED THREE TIMES, AND UPON REMOVAL, A CATHETER FRACTURE (KINK) WAS DISCOVERED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE WAS DAMAGE TO THE NITINOL CAGE. A CATHETER FRACTURE WAS REPORTED BUT REMAINED ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730254 ↗
• 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 ↗
• MalfunctionFeb 16, 2026Leak/Splash

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE CHOCOLATE 014 BALLOON, A LEAK WAS OBSERVED IN THE BALLOON WHEN INFLATED, AS CONTRAST WAS SEEN EXITING THE BALLOON AND TRAVELING DOWN THE LEFT ILIAC, SUPERFICIAL FEMORAL, AND TIBIAL/POPLIETAL TRUNK ARTERIES, WHICH WERE AFFECTED BY CALCIFIED PLAQUE. THE LEAK WAS IDENTIFIED DURING THE PROCEDURE, AND THE DEVICE WAS SAFELY REMOVED WITHOUT ISSUE. A NEW CHOCOLATE BALLOON WAS OPENED AND USED, FUNCTIONING PROPERLY WITH NO LEAK. THE PATIENT WAS ALIVE WITH NO INJURY, AND NO SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, ILLNESSES, INFECTIONS, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343461 ↗
• 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 16, 2026Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON BURST OCCURRED WITH THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CHOCOLATE 018 AND A IN. PACT DRUG COATED BALLOON 018. BOTH BALLOON BURSTS WERE NOTED DURING THE PROCEDURE FOR BOTH DEVICES, AND NEITHER BALLOON DETACHED DURING THE EVENT. BOTH DEVICES WERE SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURES WERE COMPLETED USING NEW DEVICES. THE PATIENT WAS NOT INJURED, NO INTERVENTION WAS REQUIRED, AND NO COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094389 ↗
• 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 ↗
• MalfunctionDec 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT A PERIPHERAL/ENDOVENOUS LESION WITH MODERATE CALCIFICATION IN THE MID SUPERFICIAL FEMORAL ARTERY, THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CHOCOLATE 018 BALLOON EXHIBITED DEFLATION DIFFICULTIES. THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE, AND DEFLATION ISSUES WERE NOTED DURING SUBSEQUENT INFLATION. DURING THE FOURTH INFLATION, THE NITINOL CONSTRAINING WIRE FAILED TO RETRACT INTO THE BALLOON. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH A 6-80 CB. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766954 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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