AccuStick™ II M001207100Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729201137), received between Oct 16, 2019 and Jan 14, 2026 — classified as 2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJun 16, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE MARKERBAND MOVED FROM THE ORIGINAL POSITION. AN ACCUSTICK II WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE DEVICE RO MARKER WAS NOT IN THE ORIGINAL POSITION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142620 ↗
• MalfunctionMar 6, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT MARKERBAND MALPOSITION OCCURRED. TWO ACCUSTICK II KITS WERE SELECTED FOR USE IN THE KIDNEY FOR NEPHROSTOMY DRAIN PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE SHEATHS ON THE ACCUSTICKS AND IT WAS NOTED THAT THE RO MARKERS WOULD SLIDE UP THE SHEATH IMPAIRING HIS VISION. WHEN THE DEVICE WAS ADVANCED THROUGH THE SKIN, THE MARKER STAYED AT THE SKIN AS THE DEVICE ADVANCED INTO THE PATIENT. IT HAPPENED WITH TWO DEVICES IN A ROW. THE SKIN INCISION WAS APPROPRIATE. THE PHYSICIAN COMMENTED THAT HE HAD NEVER SEEN THE MARKER SLIDE DOWN. THE SHEATHS WERE ALSO NOTED TO BE KINKED AT THE DISTAL TIP OF THE DEVICE. THE DEVICES WERE PULLED OUT INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485096 ↗
• MalfunctionMar 6, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT MARKERBAND MALPOSITION OCCURRED. TWO ACCUSTICK II KITS WERE SELECTED FOR USE IN THE KIDNEY FOR NEPHROSTOMY DRAIN PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE SHEATHS ON THE ACCUSTICKS AND IT WAS NOTED THAT THE RO MARKERS WOULD SLIDE UP THE SHEATH IMPAIRING HIS VISION. WHEN THE DEVICE WAS ADVANCED THROUGH THE SKIN, THE MARKER STAYED AT THE SKIN AS THE DEVICE ADVANCED INTO THE PATIENT. IT HAPPENED WITH TWO DEVICES IN A ROW. THE SKIN INCISION WAS APPROPRIATE. THE PHYSICIAN COMMENTED THAT HE HAD NEVER SEEN THE MARKER SLIDE DOWN. THE SHEATHS WERE ALSO NOTED TO BE KINKED AT THE DISTAL TIP OF THE DEVICE. THE DEVICES WERE PULLED OUT INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484908 ↗
• MalfunctionAug 3, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP OF THE NEEDLE BROKE OFF. AN ACCUSTICK II KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE NEEDLE BROKE OFF WHILE GETTING ACCESS. THE DEVICE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161621 ↗
• MalfunctionJan 19, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE RADIO OPAQUE MARKER WAS DETACHED. AN ACCUSTICK KIT II WAS SELECTED FOR USE. DURING THE DEVICE PREPARATION, OUTSIDE THE PATIENT 'S BODY, IT WAS NOTED THAT THE RADIO OPAQUE MARKER WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13296630 ↗
• MalfunctionNov 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THERE WAS A CRACK AT THE TIP OF THE DILATOR. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS COMMON BILE DUCT. AN ACCUSTICK II KIT WAS SELECTED FOR USE TO INSERT A DRAINAGE CATHETER. DURING THE PROCEDURE, WHEN THE PHYSICIAN WITHDREW THE DILATOR FROM THE PATIENT'S BODY, HE FOUND THAT THERE WAS A CRACK AT THE TIP OF THE DILATOR. THERE WAS A SMALL PINHOLE AND LINEAR CRACKING FOUND. NO VISIBLE SEPARATION NOR DEBRIS WAS FOUND. THE DILATOR WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY THROUGH THE GUIDEWIRE IN ACCUSTICK SET AND THE PUNCTURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10836891 ↗
• MalfunctionOct 16, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT INSIDE THE PACKAGING. AN ACCUSTICK WAS SELECTED FOR USE IN A NEPHROSTOMY PROCEDURE. UPON UNPACKING THE DEVICE, AN EYELASH WAS FOUND INSIDE THE STERILE PACKAGING. THE PHYSICIAN OPENED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED NO HARM AS THE COMPROMISED DEVICE WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 9199126 ↗