Skip to content

Screw Dilator 630838025Recalls & reported problems

Argon Medical Devices, Inc. · Screw Dilator 8F x 25cm · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00886333004911), received between Dec 9, 2020 and Dec 9, 2020 — classified as 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

Device problems

  • Break1
  • Difficult to Remove1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionDec 9, 2020Break; Difficult to Remove

    IN CONNECTION WITH DRAINAGE SYSTEMS, A SCREW DILATOR IS USED OVER THE GUIDE WIRE. THE TIP OF THE DILATOR BREAKS AND CANNOT BE PULLED OUT OF THE PATIENT AND MUST BE LEFT.

    Patient problems: Foreign Body In Patient

    MAUDE report 10980107 ↗

Other Dilator, Catheter devices

All Dilator, Catheter devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page