Exodus 10412Recalls & reported problems
Navilyst Medical, Inc. · Nuance Nephrostomy Drainage Catheter 10F x 25cm with Tight Pigtail · Class 2
All models of Exodus (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965104120), received between Nov 20, 2018 and Aug 23, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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
- Fracture2
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2022Fracture; Fracture
AN END USER REPORTED AN ISSUE WITH AN EXODUS DRAINAGE CATHETER. THE DEVICE WAS PLACED THROUGH THE PATIENT'S DUODENUM INTO THE BILIARY SYSTEM. AT A LATER TIME, THE PATIENT WAS BROUGHT IN FOR A PROCEDURE, REQUIRING REMOVAL OF THE DRAIN, AND IT WAS FOUND TO BE BROKEN INTO 3 PIECES. ALL PIECES WERE REMOVED SUCCESSFULLY, FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 15278693 ↗MalfunctionNov 20, 2018Fracture; Fracture
AS REPORTED, PATIENT WITH AN EXODUS DRAINAGE CATHETER REQUIRED IT TO BE REPLACED ON (B)(6) 2018 DUE TO A CRACKED HUB. THE USED CATHETER WAS DISCARDED AT THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8088772 ↗
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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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