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Exodus 10423Recalls & reported problems

Navilyst Medical, Inc. · Array Multipurpose Drainage Catheter 12F x 25cm with Standard Pigtail · Class 2

All models of Exodus (12)

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 H965104230), received between Jun 19, 2018 and Jun 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 19, 2018Fracture; Fracture

    AS REPORTED, EXODUS DRAINAGE CATHETER IN PLACE FOR "A FEW DAYS" AND CONNECTED TO AN ACCORDION SUCTION DRAIN. THE CATHETER HUB CRACKED AND WAS REMOVED AND REPLACED. THERE WAS NO PATIENT INJURY OR COMPLICATIONS. THE USED CATHETER WAS DISCARDED AT THE HOSPITAL.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7613606 ↗

Other CATHETER, BILIARY, DIAGNOSTIC devices

All CATHETER, BILIARY, DIAGNOSTIC devices →

Sources and updates

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