NA 1806-0073Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540195869), received between Mar 16, 2021 and Mar 9, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP OF THE TEFLON TUBE WAS BROKEN WHEN IT WAS PLACED INTO THE INTRATHECAL SPACE. NO DEBRIS REMAINED IN THE BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513844 ↗
• InjuryMar 16, 2021Material Fragmentation; Device Damaged by Another Device; Material Fragmentation; Device Damaged by Another Device

  THE CUSTOMER REPORTED THAT : "TEFLON TUBE WHICH HAS BEEN DAMAGED WITH A PIECE OF TEFLON REMOVED BY THE GUIDED STEM". UPDATE FROM REP 02/11/2021: THE LOT NUMBER IS NOT AVAILABLE BECAUSE THE PRODUCT WAS USED SO TAKEN OUT OF ITS ORIGINAL PACKAGING. THE LOT NUMBER IS NOT SHOWN ON THE DEVICE BECAUSE IT IS TEFLON (NO MARKING OR ENGRAVING). THE SURGICAL TEAM TOLD THE REP THAT, THE TEFLON TUBE "PARTIALLY DISINTEGRATED LEAVING SMALL PIECES IN THE TISSUES."

  Patient problems: Foreign Body In Patient

  MAUDE report 11498057 ↗