N/A 4324ADFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403231834), received between Apr 22, 2019 and Apr 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2019Device Dislodged or Dislocated

  PT WAS IN THE PROCESS OF RECEIVING A MYELOGRAM. DURING ONE OF THE ATTEMPTS AT ACCESS, THE OUTER PORTION OF THE SPINAL NEEDLE BECAME DISLODGED FROM THE HUB AND EMBEDDED IN THE SOFT TISSUE AND REQUIRED SUBSEQUENT RETRIEVAL. AS SUCH, FURTHER ATTEMPTS AT ACCESS WERE NOT PERFORMED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8541229 ↗