AccuStick™ II M001207020Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729157588), received between Jan 19, 2017 and Jul 16, 2026 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, 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 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 ↗
• 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 ↗
• MalfunctionJun 20, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT MARKERBAND DISPOSITION OCCURRED. A .038 J ACCUSTICK II WAS SELECTED FOR USE IN THE PERCUTANEOUS TRANSHEPATIC. DURING THE PROCEDURE, IT WAS NOTED THAT THE RO MARKER WAS MOVED OUT OF LOCATION WHILE ACCESSING THE LESION PERCUTANEOUSLY. 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 17166651 ↗
• MalfunctionJun 6, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED, THAT DEVICE CONTAMINATION OCCURRED. A .038J ACCUSTICK II SYSTEM WAS SELECTED FOR USE. PRIOR TO PROCEDURE, IT WAS NOTED, THAT A HAIR IS EVIDENT INSIDE THE PACKAGING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073089 ↗
• MalfunctionFeb 27, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT RADIOOPAQUE MARKER LOCATION WAS NOT IN ITS NORMAL POSITION. THE NON STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND NON CALCIFIED POSTERIOR BACK. A .038 J ACCUSTICK II WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RADIO PLAQUE MARKER WAS NOT IN ITS NORMAL POSITION. IT WAS DISPLACED AND FARTHER UP THE INTRODUCER THAN NORMAL. THE DEVICE WAS REMOVED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443847 ↗
• MalfunctionMay 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BREAK/FRACTURE OCCURRED. A .038 J ACCUSTICK II WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS BROKEN/FRACTURED WHILE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458527 ↗
• MalfunctionSep 28, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE MARKER WAS NOT VISIBLE. AN ACCUSTICK II WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL RADIOPAQUE MARKER WAS NOT VISIBLE ON IMAGING. THE DEVICE WAS REMOVED AND CHECKED UNDER IMAGING EXTERNALLY, IT WAS IDENTIFIED THAT THE MARKER WAS LOCATED IN THE MIDDLE OF THE NEEDLE SHAFT RATHER AT THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THERE WAS NO VISUAL ISSUE/DAMAGE NOTED ON THE DEVICE PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543921 ↗
• InjuryJul 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BROKE AND WAS LEFT INSIDE THE PATIENT THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON FEMORAL ARTERY (CFA). A .038 ACCUSTICK II WAS SELECTED FOR USE AFTER THE PHYSICIAN EXPERIENCED DIFFICULTY IN GETTING INTRA ATERIAL ACCESS. THE SHEATH WAS SUCCESSFULLY PLACED IN THE RIGHT CFA. DURING PROCEDURE, AFTER A GUIDEWIRE WAS PLACED OVER THE AORTIC BIFURCATION AND INTO THE LEFT EXTERNAL ILIAC ARTERY, THE PHYSICIAN OBSERVED A FOREIGN BODY PRESENT IN THE LEFT COMMON ILIAC ARTERY. AFTER EXAMINATION OF THE DEVICE, IT WAS DETERMINED THAT THE FOREIGN BODY WAS THE RADIOPAQUE (RO) MARKER OF THE ACCUSTICK SHEATH. SNARING WAS ATTEMPTED TO REMOVE THE RO MARKER BUT WAS UNSUCCESSFUL. CONSEQUENTLY, THE PHYSICIAN PLACED A STENT TO TRAP THE RO MARKER PREVENTING EMBOLIZATION. NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8748773 ↗
• InjuryJun 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SMALL RING WAS DETACHED FROM THE DEVICE. AN ACCUSTIC II CATHETER WAS SELECTED FOR USE. DURING WITHDRAWAL, THE PHYSICIAN NOTED THAT THE SMALL MARKING RING AT THE DISTAL END OF THE SYSTEM HAD DETACHED AND WAS STILL INSIDE THE PATIENT. THE PHYSICIAN CAREFULLY REMOVED THE DETACHED COMPONENT FROM THE PATIENT. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667406 ↗
• InjuryApr 5, 2019Break; Break

  IT WAS REPORTED VIA MEDWATCH MW5084800 THAT THE WIRE BROKE OFF AND WAS SNARED FROM THE PATINET. A .038 J-TIP WIRE ACCUSTICK II WAS USED IN A LEFT PERCUTANEOUS NEPHROLITHOTOMY PLACEMENT PROCEDURE. DURING PROCEDURE, THE WIRE OF THE ACCUSTIK II BROKE OFF INSIDE THE PATIENT. THE WIRE WAS THEN RETRIEVED USING A SNARE AND NO ADDITIONAL MONITORING NEEDED. NO FURTHER PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THERE WERE NO DEVICE FRAGMENTS LEFT IN THE PATIENT'S BODY AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8487332 ↗
• MalfunctionSep 14, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT THE MARKER BAND WAS NOT IN THE RIGHT LOCATION. A .038 ACCUSTIK II SYSTEM WAS SELECTED FOR USE. IT WAS NOTED THAT THE MARKER OF THE DEVICE WAS NOT IN THE RIGHT LOCATION ON THE DILATOR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7877442 ↗
• MalfunctionAug 9, 2017Difficult to Remove; Material Separation

  DURING NEPHROSTOMY TUBE PLACEMENT, A 6 FR INTRODUCER DILATOR SYSTEM WAS ADVANCED OVER THE 0.018 WIRE; THE WIRE WAS EXCHANGED FOR A LARGER J WIRE. WHEN RADIOLOGIST TRIED TO REMOVE THE INTRODUCER, THE METALIC TIP OF THE INTRODUCER SEPARATED FROM THE INTRODUCER AND WAS IN THE PERINEPHRIC SPACE. NUMEROUS ATTEMPTS TO REMOVE THE AVULSED DILATED TEAR WAS UNSUCCESSFUL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6787565 ↗
• MalfunctionJan 19, 2017Break

  MICRO-WIRE TIP SHEARED DURING ATTEMPTED PERCUTANEOUS NEPHROSTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6269630 ↗