COLORADO E1135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540001238), received between Jun 21, 2016 and Jun 21, 2016 — classified as 1 malfunction.

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

• MalfunctionJun 21, 2016Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING INCOMING INSPECTION A FOREIGN MATERIAL IN THE SHAPE OF A HAIR WAS FOUND IN A COLORADO NEEDLE PACKAGE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 5739526 ↗