AccuTip AT2235QRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817781020079), received between Mar 11, 2019 and Oct 29, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE DOCTOR WAS USING A 22G X 3 ½" QUINCKE NEEDLE FOR A SACROILIAC JOINT INJECTION AND WHEN SHE WENT TO REMOVE THE NEEDLE FROM THE PATIENT THE PLASTIC HUB SEPARATED FROM THE METAL NEEDLE. AN INCISION WAS MADE TO REMOVE THE NEEDLE FROM THE PATIENT AS THE NEEDLE WAS INSERTED UNDERNEATH THE SURFACE OF THE SKIN.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9252431 ↗
• MalfunctionMar 11, 2019Manufacturing, Packaging or Shipping Problem; Component Misassembled; Manufacturing, Packaging or Shipping Problem; Component Misassembled

  IT WAS REPORTED THAT THE NEEDLE INTRODUCER (STYLET) WAS LONGER THAN THE NEEDLE CANNULA BY APPROXIMATELY ONE-HALF (0.5) INCH. AS THE DEFECT WAS DISCOVERED PRIOR TO USE, THERE WAS NO RISK TO THE PATIENT AS THE NEEDLE WAS NOT USED. THE DEFECT DEVICE WAS NOT AVAILABLE FOR EXAMINATION, HOWEVER A PHOTO WAS PROVIDED OF THE DEFECT DEVICE. THE CLINIC IS RETURNING THE UNUSED PRODUCT AND IT WILL BE EXCHANGED FOR A DIFFERENT LOT OF THE SAME SIZE.

  Patient problems: No Patient Involvement

  MAUDE report 8409398 ↗