AccuStick™ II M001207040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729194514), received between Jan 8, 2019 and Feb 12, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 10, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT A MARKERBAND DETACHMENT OCCURRED AND ADDITIONAL INTERVENTION WAS REQUIRED. THE TARGET LESION WAS LOCATED IN THE KIDNEY. AN ACCUSTICK II WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE INSERTING THE INTRODUCER SHEATH, THE RADIOPAQUE MARKER BAND MOVED AWAY FROM THE TIP PREVENTING THE PHYSICIAN FROM SEEING WHERE THE TIP OF THE SHEATH WAS UNDER FLUOROSCOPY. DURING AN ATTEMPT TO ADVANCE THE SHEATH, THE KIDNEY WAS PERFORATED WITH THE TIP OF THE INTRODUCER SHEATH. ANOTHER ACCUSTICK PACKAGE WAS OPENED, AND THE SAME THING HAPPENED WITH THE NEXT 3 SHEATHS. THE MARKER BAND HAD MOVED; THE PATIENT ALREADY HAD CONTRAST IN THE KIDNEY, SO VISIBILITY WAS AN ISSUE TO BEGIN WITH. ONE OF THE MARKER BANDS FROM A DIFFERENT KIT ACTUALLY CAME COMPLETELY OFF AND HAD TO BE SNARED OUT OF THE KIDNEY ON ITS OWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708346 ↗
• MalfunctionApr 10, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT A MARKERBAND MALPOSITION OCCURRED. THE TARGET LESION WAS LOCATED IN THE KIDNEY. AN ACCUSTICK II WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE INSERTING THE INTRODUCER SHEATH, THE RADIOPAQUE MARKER BAND MOVED AWAY FROM THE TIP PREVENTING THE PHYSICIAN FROM SEEING WHERE THE TIP OF THE SHEATH WAS UNDER FLUOROSCOPY. DURING AN ATTEMPT TO ADVANCE THE SHEATH, THE KIDNEY WAS PERFORATED WITH THE TIP OF THE INTRODUCER SHEATH. ANOTHER ACCUSTICK PACKAGE WAS OPENED, AND THE SAME THING HAPPENED WITH THE NEXT 3 SHEATHS. THE MARKER BAND HAD MOVED; THE PATIENT ALREADY HAD CONTRAST IN THE KIDNEY, SO VISIBILITY WAS AN ISSUE TO BEGIN WITH. ONE OF THE MARKER BANDS FROM A DIFFERENT KIT ACTUALLY CAME COMPLETELY OFF AND HAD TO BE SNARED OUT OF THE KIDNEY ON ITS OWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708337 ↗
• MalfunctionApr 10, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT A MARKERBAND MALPOSITION OCCURRED. THE TARGET LESION WAS LOCATED IN THE KIDNEY. AN ACCUSTICK II WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE INSERTING THE INTRODUCER SHEATH, THE RADIOPAQUE MARKER BAND MOVED AWAY FROM THE TIP PREVENTING THE PHYSICIAN FROM SEEING WHERE THE TIP OF THE SHEATH WAS UNDER FLUOROSCOPY. DURING AN ATTEMPT TO ADVANCE THE SHEATH, THE KIDNEY WAS PERFORATED WITH THE TIP OF THE INTRODUCER SHEATH. ANOTHER ACCUSTICK PACKAGE WAS OPENED, AND THE SAME THING HAPPENED WITH THE NEXT 3 SHEATHS. THE MARKER BAND HAD MOVED; THE PATIENT ALREADY HAD CONTRAST IN THE KIDNEY, SO VISIBILITY WAS AN ISSUE TO BEGIN WITH. ONE OF THE MARKER BANDS FROM A DIFFERENT KIT ACTUALLY CAME COMPLETELY OFF AND HAD TO BE SNARED OUT OF THE KIDNEY ON ITS OWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708230 ↗
• InjuryApr 10, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT A MARKERBAND MALPOSITION OCCURRED AND THE KIDNEY WAS PERFORATED. THE TARGET LESION WAS LOCATED IN THE KIDNEY. AN ACCUSTICK II WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE INSERTING THE INTRODUCER SHEATH, THE RADIOPAQUE MARKER BAND MOVED AWAY FROM THE TIP PREVENTING THE PHYSICIAN FROM SEEING WHERE THE TIP OF THE SHEATH WAS UNDER FLUOROSCOPY. DURING AN ATTEMPT TO ADVANCE THE SHEATH, THE KIDNEY WAS PERFORATED WITH THE TIP OF THE INTRODUCER SHEATH. ANOTHER ACCUSTICK PACKAGE WAS OPENED, AND THE SAME THING HAPPENED WITH THE NEXT 3 SHEATHS. THE MARKER BAND HAD MOVED; THE PATIENT ALREADY HAD CONTRAST IN THE KIDNEY, SO VISIBILITY WAS AN ISSUE TO BEGIN WITH. ONE OF THE MARKER BANDS FROM A DIFFERENT KIT ACTUALLY CAME COMPLETELY OFF AND HAD TO BE SNARED OUT OF THE KIDNEY ON ITS OWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Internal Organ Perforation

  MAUDE report 16708227 ↗
• InjuryJun 16, 2022Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE RADIOPAQUE MARKER ON THE ACCUSTICK II DEVICE DISLODGED AND COULD NOT BE RETRIEVED. A .038 ACCUSTICK II WAS SELECTED FOR USE IN A PROCEDURE TREATING THE LIVER. WHILE REMOVING THE 6 FRENCH ACCUSTICK DILATOR FROM THE PATIENT, MILD RESISTANCE WAS FELT AT THE LIVER CAPSULE. A GENTLE TRACTION WAS MAINTAINED AND THE DEVICE WAS REMOVED; HOWEVER, THE DISTAL CIRCULAR RADIOPAQUE MARKER OF THE OUTER 6 FRENCH SHEATH WAS RETAINED WITHIN THE ACCESS TRACT. A 6 FRENCH VASCULAR SHEATH WAS THEN ADVANCED OVER THE WIRE, AND THE RADIOPAQUE MARKER RE-ADVANCED OVER THE WIRE. AN ATTEMPT WAS MADE TO ENGAGE THE MARKER INTO THE SHEATH USING THE CURVED TIP OF THE NON-BOSTON SCIENTIFIC (BSC) WIRE THAT HAD CAUGHT ON THE MARKER, BUT THIS WAS UNSUCCESSFUL AS THE MARKER DISPLACED FROM THE 6 FRENCH SHEATH. THE MARKER BECAME LODGED IN A DISTAL SPLENIC VEIN BRANCH. THIS WAS ACCESSED WITH A NON-BSC GUIDEWIRE AND CATHETER, AND ANOTHER ATTEMPT WAS MADE TO REMOVE THE MARKER; HOWEVER, IT DID NOT DISLODGE. THE SHEATH WAS THEN UPSIZED TO AN 8 FRENCH, AND FURTHER ATTEMPTS AT FLUOROSCOPIC-GUIDED RETRIEVAL OF THE MARKER THROUGH THE SHEATH WITH A NON-BSC WIRE AND SNARE WERE ALSO UNSUCCESSFUL. ATTENTION W

  Patient problems: Foreign Body In Patient

  MAUDE report 14712934 ↗
• MalfunctionJun 4, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN/FRACTURED. AN ACCUSTICK II INTRODUCER CATHETER WAS SELECTED FOR USE IN A DRAINAGE PROCEDURE. DURING PREPARATION, THE DEVICE WAS REPORTED TO BREAK AND/OR FRACTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER ACCUSTICK II. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT UPON INSERTION, IT WAS NOTICED THAT THE TIP BELOW THE MARKER HAD A TEAR OR SPLIT IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939921 ↗
• MalfunctionJan 8, 2019Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. THE TARGET AREA WAS LOCATED IN THE KIDNEY. A .038 ACCUSTICK II WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE ACCUSTICK WIRE WAS PLACED IN AND THEN THE DILATOR OVER THE WIRE, IT WAS NOTED THAT THE WIRE WAS KINKED. THE PHYSICIAN PULLED OUT THE WIRE; HOWEVER, IT UNRAVELED AND A PORTION OF THE DEVICE STAYED IN THE PATIENT'S KIDNEY. CONSEQUENTLY, THE PHYSICIAN PUT THE INNER STIFFENER OVER THE WIRE TO PROVIDE STABILITY AND TO REMOVE THE WIRE. THIS WAS UNSUCCESSFUL. THERE WAS NO OTHER OPTION BUT TO REMOVE THE WIRE SURGICALLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS POST-PROCEDURE WAS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8228665 ↗