Skip to content

Edge SD45EWCTE-FTRecalls & reported problems

Covidien LP · Firm Tip;Extended Working Channel;45 Catheter · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521199576), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

Device problems

  • Material Fragmentation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 6, 2019Material Fragmentation; Material Fragmentation

    ACCORDING TO THE REPORTER DURING A PROCEDURE, THERE WAS A PLASTIC STRING PROTRUDING FROM THE EXTENDED WORKING CHANNEL. THE PHYSICIAN IS STILL ABLE TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8395812 ↗

Other System, x-ray, tomography, computed devices

All System, x-ray, tomography, computed devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.