AccuStick™ II M001207050Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729157625), received between Dec 18, 2018 and Mar 24, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 1, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT MARKERBAND MALPOSITION OCCURRED. AN ACCUSTICK II WAS SELECTED FOR USE IN THE PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD). DURING THE PROCEDURE, IT WAS NOTED THAT THE MARKER POSITION WAS BEHIND THE ORIGINAL POSITION. THE DEVICE WAS REMOVED FROM THE PATIENT 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 16279203 ↗
• MalfunctionMar 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01MAR2022. IT WAS REPORTED THAT THE DEVICE COULD NOT ADVANCE IN THE SHEATH AND THE SHEATH CAME OUT. AN ACCUSTICK II WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE GOT JAMMED IN THE SHEATH AND THE SHEATH EVENTUALLY CAME OUT. THE DEVICE WAS REPLACE WITH ANOTHER OF SAME MODEL BUT THE SAME PROBLEM OCCURRED REPEATEDLY. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH DILATOR WAS TORN AT THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866577 ↗
• MalfunctionMar 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01MAR2022. IT WAS REPORTED THAT THE DEVICE COULD NOT ADVANCE IN THE SHEATH AND THE SHEATH CAME OUT. AN ACCUSTICK II WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE GOT JAMMED IN THE SHEATH AND THE SHEATH EVENTUALLY CAME OUT. THE DEVICE WAS REPLACE WITH ANOTHER OF SAME MODEL BUT THE SAME PROBLEM OCCURRED REPEATEDLY. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH DILATOR WAS TORN AT THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866573 ↗
• MalfunctionFeb 1, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ACCUSTICK II W/O GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE IS JAMMED IN THE SHEATH AND THE SHEATH COMES OUT. THE DEVICE WAS REPLACED WITH THE SAME PRODUCT, HOWEVER, THE SAME ISSUE WAS ENCOUNTERED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419884 ↗
• MalfunctionFeb 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. AN ACCUSTICK II WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD). DURING PREPARATION, IT WAS NOTED THAT THE TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9711278 ↗
• MalfunctionJan 16, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP WAS TORN. THE TARGET LESION AREA WAS LOCATED IN THE LIVER. AN ACCUSTICK II WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE TIP WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9595795 ↗
• MalfunctionMar 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RADIOPAQUE MARKER WAS NOT IN THE POSITION. AN ACCUSTICK LL CATHETER WAS SELECTED FOR USE FOR A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE PROCEDURE. DURING PREPARATION, IT WAS FOUND OUT THAT THE RADIOPAQUE MARKER WAS MARKED ONLY IN THE PROXIMAL PORTION OF THE CATHETER, WHEN IT IS NORMALLY MARKED ON THE DISTAL SECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8413218 ↗
• MalfunctionDec 18, 2018Break; Break

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE WAS SPLIT. AN ACCUSTICK II GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE END POINT OF THE WIRE WAS SPLIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8173675 ↗