Epimed 105-1314Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818788020079), received between Nov 12, 2025 and Nov 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K053318); they may or may not involve this specific model.

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.

• MalfunctionNov 12, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRIAL PROCEDURE, DURING THE PROCEDURE PHYSICIAN WAS UNABLE TO GAIN ACCESS TO THE EPIDURAL SPACE. PER PHYSICIAN, THIS ISSUE WAS NOT PROCEDURE OR DEVICE RELATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534339 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053318. One submission often covers many models, so check the product and lot details in each record.

• Z-0087-2018 · Jul 24, 2017 · Terminated
  RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter