AccuStick IIRecalls & reported problems across all models

We found 5 models of AccuStick II by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2017 and Jul 16, 2026 — classified as 12 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Defective Device” (20 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 AccuStick II problems

AccuStick II models

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

• AccuStick™ II M001207020

  ACCESSORIES, CATHETER
  15 reports
• AccuStick™ II M001207100

  ACCESSORIES, CATHETER
  12 reports
• AccuStick™ II M001207050

  ACCESSORIES, CATHETER
  11 reports
• AccuStick™ II M001207040

  ACCESSORIES, CATHETER
  10 reports
• AccuStick™ II M001207030

  ACCESSORIES, CATHETER
  3 reports

Recent AccuStick II adverse event reports

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

• InjuryJul 16, 2026Fracture

  It was reported that the microwire fractured, requiring additional intervention.During placement of a left renal abscess drain, an Accustick II system was selected for use. While manipulating the microwire, a portion of the microwire sheared off and remained within the patient. Because infected urine was present, only minimal retrieval attempts were made during the initial procedure. Nine days later, the patient returned for percutaneous retrieval of the retained wire fragment during removal of the indwelling abscess drain. Retrieval using a snare was unsuccessful, and the retained fragment could not be removed percutaneously. Further management with retrograde ureteroscopy or surgery was recommended if clinically indicated. The patient was expected to fully recover, and no patient complications were reported as a result of this event.

  Patient problems: Foreign Body In Patient

  MAUDE report 25847611 ↗
• MalfunctionMay 15, 2026Nonstandard Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED AND REMAINED INSIDE THE PATIENT. THE VASCULAR ACCESS WAS THROUGH THE LEFT HEPATIC DUCT. A 0.038 J ACCUSTICK II WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) WITH PLACEMENT OF LEFT INTERNAL/EXTERNAL BILIARY DRAIN. UPON ACCESS INTO THE BILIARY TREE AND DURING MANIPULATION OF THE WIRE, IT WAS DISCOVERED THAT THE WIRE HAD KINKED. CONSEQUENTLY, THE DISTAL TIP SHEARED OFF DURING CONTINUED MANIPULATION. THE TIP REMAINED IN THE BILIARY SYSTEM AND WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25186854 ↗
• MalfunctionMar 24, 2026Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RADIO OPAQUE TIP FELL OFF. AN ACCUSTICK WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN REMOVING THE DEVICE, IT WAS NOTED THAT THE RADIO OPAQUE TIP FELL OFF AND WAS RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTER THAT THE RADIO OPAQUE TIP WHEN RETRIEVED WAS BARELY ON WHEN REMOVED AND THEN FELL OFF WHEN IT WAS OUT OF THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676234 ↗
• MalfunctionMar 2, 2026Nonstandard Device

  IT WAS REPORTED THAT THE MARKER BAND WAS NOT FIXED IN PLACE AND WAS MOVING. DURING THE PROCEDURE WHILE USING THIS ACCUSTICK II DEVICE, IT WAS NOTED THAT THE MARKER BAND WAS NOT FIXED IN PLACE AND WAS MOVING. THEREFORE, ANOTHER ACCUSTICK DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490073 ↗
• MalfunctionFeb 12, 2026Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE GOT STUCK WITH THE MICROWIRE. THE TARGET LESION WAS LOCATED IN THE LEFT KIDNEY. THE PATIENT HAD A LARGE RENAL PELVIS STONE AND NEEDED A NEPHROURETERAL CATHETER PLACEMENT FOR A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) WITH UROLOGY. AN .038 ACCUSTICK II INTRODUCER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ACCUSTICK SET WAS USED TO GAIN ACCESS STARTING WITH THE INTRODUCER NEEDLE WITH STYLET. ONCE PROPER ACCESS WAS ACHIEVED, THE STYLET WAS REMOVED AND THE MICRO WIRE WAS INSERTED. THE NEEDLE WAS THEN EXCHANGED FOR THE CO-AXIAL INTRODUCER. HOWEVER, UPON INSERTION OF THE INTRODUCER INTO THE PATIENT'S RENAL PELVIS, THE MICRO WIRE BECAME STUCK WITHIN THE INTRODUCER, PREVENTING REMOVAL OF THE INNER DILATOR AND MICRO WIRE. AS A RESULT, THE ACCESS SITE WAS ABANDONED, AND A NEW ACCUSTICK II SET WAS USED TO RESTART THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327772 ↗
• MalfunctionJan 14, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HUB DETACHMENT OCCURRED. A ACCUSTICK II WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE GOT BROKEN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24070324 ↗
• InjuryJun 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. AN ACCUSTICK II WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE CAME APART WHILE INSIDE THE PATIENT. A BALLOON WAS PLACED PAST THE BROKEN ACCUSTICK TO RETRIEVE, HOWEVER THE BALLOON POPPED. A SECOND BALLOON WAS USED AND WAS ABLE TO PULL IT BACK OVER THE WIRE THAT WAS IN PLACE. THE DEVICE WAS REMOVED IN 2 (TWO) PIECES AND PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186948 ↗
• InjuryAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE DETACHED INSIDE THE PATIENT. ON (B)(6) 2024, A PATIENT UNDERWENT A RIGHT NEPHROSTOMY TUBE PLACEMENT PROCEDURE DURING WHICH A GUIDEWIRE BROKE, LEAVING A 30.2 CM PORTION RETAINED IN THE PATIENT'S RIGHT KIDNEY PELVIS. THE RADIOLOGIST REPORTED THAT NO UNDUE STRESS, SUCH AS TUGGING, PUSHING, OR PULLING, WAS APPLIED TO THE GUIDEWIRE PRIOR TO ITS BREAKAGE, AND THE BROKEN SEGMENT COULD NOT BE RETRIEVED DURING THE INITIAL PROCEDURE. SUBSEQUENT TO THE INCIDENT, THE PATIENT REQUIRED TWO ADDITIONAL PROCEDURES TO ADDRESS THE RETAINED GUIDEWIRE. ON (B)(6) 2024, A RIGHT URETEROSCOPIC LASER LITHOTRIPSY WAS PERFORMED WITH THE AIM OF REMOVING THE FOREIGN BODY. DURING THIS PROCEDURE, A 1.6 CM PIECE OF THE GUIDEWIRE WAS SUCCESSFULLY EXTRACTED FROM THE RIGHT KIDNEY PELVIS; HOWEVER, THE REMAINING PORTION COULD NOT BE REMOVED. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2024, INVOLVING A RIGHT PARTIAL URETERECTOMY AND URETEROPYELOSTOMY WITH DOUBLE-J STENT PLACEMENT. THIS PROCEDURE SUCCESSFULLY REMOVED THE REMAINING 28.6 CM PORTION OF THE GUIDEWIRE. THE PATIENT CONDITION REMAINED STABLE, AND THERE WERE NO ADVERSE EFFECTS FROM THE RETAINED GUIDEWIRE. THE PATIENT WAS DISCHA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015520 ↗
• MalfunctionFeb 9, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT MARKERBAND DISPOSITION OCCURRED. A: 038 ACCUSTICK II WAS SELECTED FOR USE IN THE NEPHROSTOMY CATHETER PLACEMENT. DURING THE PROCEDURE, THE RADIOPAQUE (RO) MARKER STARTED IN ITS ORIGINAL POSITION. HOWEVER, UPON INSERTION INTO THE PATIENT, IT WAS NOTED THAT THE RO SLID BACK ON THE INTRODUCER. THE DEVICE WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676151 ↗
• MalfunctionJan 3, 2024Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MARKERBAND WAS DISLODGED. THE TARGET LESION WAS LOCATED IN THE KIDNEY. AN ACCUSTICK II W/O GUIDEWIRE WAS SELECTED FOR USE. AFTER WITHDRAWING THE DEVICE FROM THE PATIENT, IT WAS NOTED THAT THE SILVER MARKERBAND WAS FOUND IN THE UPPER PART OF THE DILATOR AND NOT AT THE END OF THE INTRODUCER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438597 ↗
• MalfunctionDec 11, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT MARKERBAND DISPOSITION OCCURRED. THE TARGET LESION WAS LOCATED IN THE BILE DUCT. AN ACCUSTICK II WAS SELECTED FOR USE IN THE PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM. DURING THE PROCEDURE, IT WAS NOTED THAT THE RADIOPAQUE (RO) MARKER IS VERY NEAR THE SHAFT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NEW ACCUSTICK. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18303800 ↗
• MalfunctionSep 18, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE RO MARKER MOVED ALONG THE CATHETER SHAFT. THIS ACCUSTICK II INTRODUCER CATHETER WAS SELECTED FOR USE TO TREAT BILIARY DUCT OBSTRUCTION. DURING PERCUTANEOUS INSERTION, THE RO MARKER SLID BACK ALONG THE SHEATH PROXIMALLY TOWARD THE PHYSICIAN'S HANDS. IT WAS CONFIRMED THAT THE RO MARKER DIDN'T DETACH/SEPARATE FROM THE TIP OF THE DEVICE (ONLY SLID BACK). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764702 ↗
• MalfunctionSep 14, 2023Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RO MARKER WAS PUSHED. THE TARGET LESION WAS LOCATED IN THE BILIARY. A ACCUSTICK II W/O GUIDIWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DILATOR WAS INSERTED INTO THE PATIENT, BUT COULD NOT SEE THE ANGIOMARK. THE DEVICE WAS REMOVED FROM THE PATIENT AND FOUND THAT THE ANGIOMARK WAS PUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745337 ↗
• InjurySep 13, 2023Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RADIOPAQUE MARKER WAS LEFT IN THE PATIENT. THE TARGET LESION WAS LOCATED IN THE LEFT KIDNEY. A NEW NEPHOSTROMY TUBE IS BEING PLACED AND A .038 ACCUSTICK II INTRODUCER SYSTEM WAS SELECTED FOR USE. A .018 WIRE AND AMPLATZ GUIDEWIRE WAS PLACED THROUGH THE 0.38 LUMEN. DURING REMOVAL OF THE DILATOR FROM THE PATIENT, THE RADIOPAQUE MARKER WAS RETAINED IN THE SKIN. THE RADIOPAQUE MARKER WAS ATTEMPTED TO RETRIEVE PERCUTANEOUSLY WITH HEMOSTATS, A DILATOR AND A NON-BOSTON SCIENTIFIC BALLOON CATHETER, BUT IT WAS UNSUCCESSFUL. EVENTUALLY, A NEPHROSTOMY TUBE WAS THEN PLACED, AND THE RADIOPAQUE MARKER WAS LEFT IN THE RENAL PELVIS. THE PATIENT IS DOING FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17741274 ↗
• MalfunctionAug 24, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE RADIOPAQUE MARKER WAS IN THE WRONG SPOT. A .038 ACCUSTICK II WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE RADIOPAQUE MARKER WAS IN THE WRONG SPOT. THERE WAS NO HARM TO THE PATIENT, AS IT WAS DETECTED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618461 ↗

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