Exodus 10540Recalls & reported problems
Navilyst Medical, Inc. · Array Multipurpose Drainage Catheter 8F 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965105400), received between Feb 21, 2020 and Jul 23, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (3 reports).
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
- Crack3
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2020Crack; Crack
AN END USER REPORTED THAT A PATIENT PRESENTED TO INTERVENTIONAL RADIOLOGY WITH AN EXODUS 8FR MULTIPURPOSE DRAINAGE CATHETER THAT HAD A BROKEN HUB, 3 DAYS AFTER INITIAL PLACEMENT. THE DRAINAGE CATHETER WAS ULTIMATELY REMOVED AND REPLACED AND THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10316960 ↗MalfunctionFeb 21, 2020Crack; Crack
AN EXODUS MULTIPURPOSE DRAINAGE CATHETER WAS PLACED IN A PATIENT. POST PROCEDURE, IT WAS NOTED THE HUB OF THE CATHETER WAS CRACKED. THE DRAIN WAS REMOVED AND REPLACED. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9740977 ↗MalfunctionFeb 21, 2020Crack; Crack
AN EXODUS MULTIPURPOSE DRAINAGE CATHETER WAS PLACED IN A PATIENT. 2 DAYS LATER, IT WAS NOTED THE HUB OF THE CATHETER WAS CRACKED. THE DRAIN WAS REMOVED AND REPLACED. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9740975 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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