Exodus 10522Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H965105220), received between Mar 13, 2020 and Aug 31, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2021Fracture; Fracture

  THE PATIENT HAS A HISTORY OF COMMON BILE DUCT INJURY AND LIVES WITH BILIARY STENTS WHICH ARE PERIODICALLY EXCHANGED, SO THE EXODUS DRAINAGE CATHETER IS USED AS AN ACCESS HOLDER TO FACILITATE THESE EXCHANGES. THE PATIENT ALSO HAS SEVERE STENOSIS OF THE LEFT BILIARY SYSTEM AND HEPATICOJEJUNOSTOMY. THE CATHETER IS PLACED PERCUTANEOUSLY INTO THE JEJUNUM AND UP INTO THE BILIARY TREE WHERE THE TIP RESIDES.

  Patient problems: Foreign Body In Patient

  MAUDE report 12391378 ↗
• MalfunctionMar 7, 2021Crack; Crack

  AN INTERVENTIONAL RADIOLOGIST REPORTED AN ISSUE WITH AN EXODUS MULTIPURPOSE DRAINAGE CATHETER 12F 25 CM. THE DOCTOR REPORTED HAVING TO REPLACE ANOTHER DRAIN DUE TO OUR 12F EXODUS MP DRAIN CRACKING AT THE HUB. THIS PATIENT EXPERIENCED A CRACKED HUB, THE DAY PRIOR (PR (B)(4)). THE DOCTOR BROUGHT THE PATIENT IN TO PLACE AN ADDITIONAL DRAIN AND NOTICED THAT THE CURRENT DRAIN WAS NOT HOLDING SUCTION. AT THAT TIME, A CRACK IN THE HUB WAS DISCOVERED. THE PATIENT WAS AN INPATIENT. IT WAS REPORTED CLAMPS WERE NOT USED FOR TIGHTENING AND CHLOROPREP WAS USED AS THE CLEANING AGENT.THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429668 ↗
• MalfunctionFeb 17, 2021Crack

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH AN EXODUS MULTIPURPOSE DRAINAGE CATHETER. POST PROCEDURE, THE PATIENT WENT FOR A SCAN AND THE CT TECHNICIAN NOTICED THAT THE DRAIN WAS NOT HOLDING SUCTION. THE DOCTOR THEN NOTICED THAT THE HUB WAS CRACKED. ULTIMATELY, THE DRAIN WAS REPLACED WITH A NEW ONE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339863 ↗
• MalfunctionMar 13, 2020Crack; Crack

  AS REPORTED: A PATIENT HAD A CRACKED HUB ON OUR EXODUS 12F MULTIPURPOSE DRAINAGE CATHETER. THIS WAS DISCOVERED ON (B)(6) 2020. THEY SAID THAT AFTER THE DRAIN WAS PLACED, THE PATIENT WENT TO THE 2ND FLOOR. THE DRAIN WAS CRACKED SOMEHOW THERE. I VISITED THE NURSING STAFF AND THEY CLAIM THEY DID NOT USE ANY DEVICE TO UNSCREW THE DUMP BAG FROM THE HUB OF THE DRAIN. THUS, WE DO NOT KNOW THE CAUSE OF THE CRACKED HUB. THE CATHETER WAS REMOVED AND REPLACED. NO PATIENT HARM OR INJURY DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9829109 ↗