Exodus 10151Recalls & reported problems
Navilyst Medical, Inc. · Array Multipurpose Drainage Catheter 10F 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
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI H965101510), received between Jun 2, 2016 and Oct 21, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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
- Fracture7
- Crack3
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient7
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025Crack; Crack
AN ANGIODYNAMICS TERRITORY MANAGER RECEIVED NOTIFICATION FROM AN END-USER FACILITY THAT REPORTED A 10F EXODUS DRAINAGE CATHETER HUB CRACK OCCURRED APPROXIMATELY 1 TO 2 DAYS POST PLACEMENT. AS A RESULT OF THE ISSUE, THE PATIENT'S DEVICE WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348292 ↗MalfunctionOct 21, 2025Crack; Crack
AN ANGIODYNAMICS TERRITORY MANAGER RECEIVED NOTIFICATION FROM AN END-USER FACILITY THAT REPORTED A 10F EXODUS DRAINAGE CATHETER HUB CRACK OCCURRED APPROXIMATELY 1 TO 2 DAYS POST PLACEMENT. AS A RESULT OF THE ISSUE, THE PATIENT'S DEVICE WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348290 ↗MalfunctionOct 21, 2025Crack; Crack
AN ANGIODYNAMICS TERRITORY MANAGER RECEIVED NOTIFICATION FROM AN END-USER FACILITY THAT REPORTED A 10F EXODUS DRAINAGE CATHETER HUB CRACK OCCURRED APPROXIMATELY 1 TO 2 DAYS POST PLACEMENT. AS A RESULT OF THE ISSUE, THE PATIENT'S DEVICE WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23348289 ↗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 7613605 ↗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 HAS BEEN RETURNED TO ANGIODYNAMICS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7613603 ↗MalfunctionFeb 28, 2017Fracture; Fracture
EXODUS DRAINAGE CATHETER PLACED ON (B)(6) 2017 FOR FLUID COLLECTION IN THE RIGHT GLUTEAL. HUB OF CATHETER CRACKED WHILE PATIENT WAS AT HOME, REQUIRING CATHETER TO BE REMOVED AND REPLACED ON (B)(6) 2017. NO COMPLICATIONS OR SERIOUS INJURY TO PATIENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6365687 ↗MalfunctionFeb 28, 2017Fracture; Fracture
EXODUS DRAINAGE CATHETER PLACED ON (B)(6) 2017 FOR FLUID COLLECTION IN THE RIGHT GLUTEAL. HUB OF CATHETER CRACKED WHILE PATIENT WAS AT HOME, REQUIRING CATHETER TO BE REMOVED AND REPLACED ON (B)(6) 2017. NO COMPLICATIONS OR SERIOUS INJURY TO PATIENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6365648 ↗MalfunctionFeb 28, 2017Fracture; Fracture
EXODUS DRAINAGE CATHETER PLACED ON (B)(6) 2017 FOR FLUID COLLECTION IN THE RIGHT GLUTEAL. HUB OF CATHETER CRACKED WHILE PATIENT WAS AT HOME, REQUIRING CATHETER TO BE REMOVED AND REPLACED ON (B)(6) 2017. NO COMPLICATIONS OR SERIOUS INJURY TO PATIENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6365486 ↗MalfunctionFeb 28, 2017Fracture; Fracture
EXODUS DRAINAGE CATHETER PLACED ON (B)(6)2017 FOR PELVIC ABSCESS. HUB OF CATHETER CRACKED WHILE PATIENT WAS AT HOME, REQUIRING CATHETER TO BE REMOVED AND REPLACED ON (B)(6) 2017. NO COMPLICATIONS OR SERIOUS INJURY TO PATIENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6365402 ↗MalfunctionJun 2, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
AS REPORTED BY END USER HOSPITAL, "THE PATIENT HAD A PANCREATIC PSEUDO CYST WITH A DRAINAGE CATHETER IN PLACE. THE CATHETER BEGAN TO LEAK AROUND THE INSERTION SITE. ON INVESTIGATION, THE CATHETER WAS FOUND TO BE CRACKED IN SEVERAL PLACES. THIS RESULTED IN THE DRAIN HAVING TO BE REPLACED."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5694501 ↗
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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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