Exodus 10526Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI H965105260), received between Nov 20, 2018 and Aug 17, 2023 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2023Fracture; Fracture

  THE PATIENT'S EXODUS BILIARY DRAINAGE CATHETER HAD BEEN INDWELLING FOR 2 MONTHS, AND DURING A CHECK-UP IMAGING SHOWED THE CATHETER HAD FRACTURED INSIDE THE PATIENT. DURING REMOVAL OF THE DEVICE, IT SEPARATED WHICH REQUIRED THE PHYSICIAN TO USE A SNARE TO RETRIEVE THE BROKEN PIECES; ALL FRAGMENTS WERE REMOVED. THE DEVICE WAS REPLACED WITH A TOTAL ABCESSION DRAINAGE CATHETER. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565766 ↗
• InjuryJun 22, 2023Fracture; Fracture

  THE PATIENT HAD THE EXODUS BILIARY DRAINAGE CATHETER 10F 35 CM STD LOOP W/ RADIOPAQUE MARKER BAND CATHETER PLACED ON (B)(6) 2023. AS A PRECAUTION , DUE TO A PREVIOUS CATHETER FRACTURE, THEY DID NOT WANT TO WAIT THE FULL 3 MONTHS TO REPLACE THIS CATHETER, SO THEY SCHEDULED A REPLACEMENT FOR (B)(6) 2023. ON (B)(6) 2023, WHEN THEY PERFORMED A SCAN PRIOR TO REMOVAL, THEY COULD SEE CATHETER WAS FRACTURED, BUT PIECES HADN'T BROKEN OFF YET. THEY WERE ABLE TO PULL OUT THE CATHETER IN ONE PIECE, BUT COULD SEE SEVERAL PLACES WHERE CATHETER WAS BREAKING DOWN AND ABOUT TO BREAK OFF. THE PATIENT WAS UNHARMED AND THEY PLACED A NEW DRAINAGE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 17184938 ↗
• InjuryJun 22, 2023Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH AN EXODUS BILIARY DRAINAGE CATHETER 10F 35 CM STD LOOP W/ RADIOPAQUE MARKER BAND. APPROXIMATELY 3 MONTHS POST PLACEMENT, THE PATIENT PRESENTED FOR A THREE MONTH CHECK UP. DURING THE CHECK UP, A SCAN WAS PERFORMED AT WHICH TIME IT WAS NOTICED THE CATHETER HAD FRACTURED INTO SEVERAL PIECES. THEY WERE ABLE TO REMOVE MOST OF THE FRAGMENTS AND A NEW DRAIN WAS PLACED. THE PATIENT WAS THEN SCHEDULED FOR SURGERY TO REMOVE THE REMAINING FRAGMENTS (B)(6) 2023). DURING THE SURGERY, THE SECOND CATHETER THAT WAS PLACED WAS REMOVED (NO FUNCTIONAL ISSUES), ALL REMAINING FRAGMENTS WERE SUCCESSFULLY REMOVED, AND A NEW CATHETER WAS PLACED. IT WAS REPORTED THE PATIENT WAS DOING FINE, AND THERE WAS NO HARM OR INJURY DUE TO THIS ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17184926 ↗
• MalfunctionApr 28, 2023Fracture; Fracture

  THE BILIARY DRAINAGE CATHETER, 10F 35 CM STD LOOP W/ RADIOPAQUE MARKER BAND DRAIN WAS IN PATIENT LESS THEN 90 DAYS, WHEN IT FRACTURED IN THE PATIENT. THEY HAD TO PERFORM A FOREIGN BODY PROCEDURE TO GET THE REMAINING DRAIN MATERIAL. THE DRAIN WAS REPLACED WITH A NEW OF THE SAME DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16833150 ↗
• InjuryOct 3, 2019Fracture; Fracture

  PATIENT WAS BROUGHT IN FOR BILIARY REMOVAL/EXCHANGE AND BEFORE STARTING THE PROCEDURE IMAGING SHOWED THAT THE CATHETER WAS BROKEN IN 4 SPOTS. THE MAIN PORTION OF THE CATHETER WAS REMOVED WITH THE DISTAL END REMAINING INSIDE THE PATIENT. ATTEMPTS WERE MADE TO RETRIEVE THE REMAINING CATHETER TIP THAT HAD LOOKED TO BE BROKEN UP BUT THEY WERE UNSUCCESSFUL. THERE WAS A STENT IN PLACE THAT THEY HAD TO WORK THROUGH WHICH MADE IT VERY DIFFICULT TO RETRIEVE THE REMAINING CATHETER FRAGMENTS. PROCEDURE WAS COMPLETED. CATHETER WAS ORIGINALLY PLACED ON (B)(6) 2019. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9152537 ↗
• InjuryDec 11, 2018Fracture; Fracture

  AS REPORTED BY HOSPITAL IN (B)(6), CATHETER USED FOR INTERNAL/EXTERNAL BILIARY DRAINAGE HAD BEEN PLACED (B)(6) 2018 AND WAS REMOVED (B)(6) 2018. UPON RETRIEVAL OF CATHETER, IT WAS NOTED THAT THE CATHETER HAD "MILD DEGRADATION." THE USED CATHETER HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8151221 ↗
• InjuryDec 7, 2018Fracture; Migration; Fracture; Migration

  AS REPORTED 10F DRAINAGE CATHETER WHICH HAD BEEN IN PLACE IN THE BILIARY TREE (DUODENUM) FOR 3 WEEKS, FRACTURED. THE PHYSICIAN HAD TO REMOVE THE TIP VIA A SNARE. THE USED CATHETER HAS BEEN RETURNED TO ANGIODYNAMICS. THE PATIENT CONDITION WAS REPORTED AS, "UNAFFECTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8141227 ↗
• 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 8088773 ↗