Exodus 10527Recalls & reported problems
Navilyst Medical, Inc. · Believe Biliary Drainage Catheter 12F x 35cm with Standard Pigtail · Class 2 · Implant
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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965105270), received between Dec 11, 2018 and Feb 20, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Migration1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- 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.
MalfunctionFeb 20, 2025Fracture; Fracture
AN END USER REPORTED AN ISSUE WITH AN EXODUS BILIARY DRAINAGE CATHETER 12F 35 CM STD LOOP W/ RADIOPAQUE MARKER BAND, PRIOR TO OR DURING THE REMOVAL OF THE BILIARY DRAINAGE CATHETER, IT WAS NOTED THE TUBE WAS FRACTURED. THE MEDICAL TEAM WAS ABLE TO RETRIEVE ALL PIECES OF THE TUBE AND A NEW TUBE WAS PLACED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21421713 ↗InjuryMay 12, 2020Fracture; Fracture
AN ANGIODYNAMICS REGIONAL BUSINESS MANAGER REPORTED THAT DURING A BILIARY EXCHANGE, PHYSICIAN NOTICED THE EXODUS BILIARY DRAINAGE CATHETER'S DRAIN WAS "FRACTURED." THE APPROXIMATE INDWELL TIME WAS 90 DAYS. A WIRE WAS INSERTED INTO THE DRAIN TO ATTEMPT TO REMOVE THE ENTIRE DRAIN; HOWEVER, THIS WAS UNSUCCESSFUL SO PATIENT WAS SENT TO SURGERY WHERE IT WAS REMOVED ENDOSCOPICALLY. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10048576 ↗InjuryDec 11, 2018Fracture; Migration; Fracture; Migration
AS REPORTED BY HOSPITAL IN (B)(6), CATHETER USED FOR INTERNAL/EXTERNAL BILIARY DRAINAGE HAS FRAGMENTED WITHIN THE PATIENT. CATHETER HAD BEEN PLACED (B)(6) 2018 AND WAS REMOVED (B)(6) 2018. UPON RETRIEVAL OF CATHETER, IT WAS NOTED THAT IT WAS "PARTIALLY FRAGMENTED." THE USED CATHETER HAS BEEN RETURNED TO (B)(4) FOR EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 8151224 ↗
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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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