Exodus 10562Recalls & reported problems
Navilyst Medical, Inc. · Array Multipurpose Drainage Catheter 14F 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 H965105620), received between Feb 16, 2021 and Feb 16, 2021 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2021Crack; Crack
A RADIOLOGY TECHNICIAN REPORTED AN ISSUE WITH A EXODUS MULTIPURPOSE 25 CM DRAINAGE CATHETER. DURING A CHECK OF THE CATHETER, IT WAS NOTED THAT THE DRAIN HAD LOST SUCTION AND THE HUB WAS FOUND TO BE CRACKED. THE DRAIN WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DRAINAGE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 11335679 ↗
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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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