Exodus 10143Recalls & 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 H965101430), received between May 2, 2016 and May 7, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (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.
Reports received per month
Most reported problems
Device problems
- Crack1
- Failure to Disconnect1
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2025Crack; Crack
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING AN EXODUS MULTIPURPOSE, DRAINAGE CATHETER, 8F, 25 CM, STD LOOP. IT WAS REPORTED THE PATIENT'S DRAINAGE CATHETER WAS CRACKED, REQUIRING REMOVAL AND REPLACEMENT. THE DRAIN HAD BEEN PLACED IN THE RIGHT POSTERIOR FLANK. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21977282 ↗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 7613607 ↗MalfunctionMay 2, 2016Failure to Disconnect; Failure to Disconnect
AS REPORTED BY END USER HOSPITAL IN (B)(6), THE PATIENT WENT TO THE EMERGENCY ROOM BECAUSE THE DRAINAGE BAG COULD NOT BE DISCONNECTED FROM THEIR DRAINAGE CATHETER. THE EMERGENCY STAFF COULD NOT DISCONNECT THE BAG, SO THE PATIENT WAS SENT TO IR, WHERE THE DRAINAGE CATHETER WAS REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5623693 ↗
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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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