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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 3 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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

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