ExodusRecalls & reported problems across all models
Navilyst Medical, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 12 models of Exodus by Navilyst Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between May 2, 2016 and Oct 21, 2025 — classified as 17 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Fracture” (41 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Exodus problems
Device problems
- Fracture41
- Crack15
- Migration7
- Use of Device Problem2
- Failure to Disconnect1
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient19
- No Clinical Signs, Symptoms or Conditions16
- Foreign Body In Patient15
- Device Embedded In Tissue or Plaque7
- No Consequences Or Impact To Patient2
Exodus models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Exodus 10525CATHETER, BILIARY, DIAGNOSTIC21 reports
- Exodus 10151CATHETER, BILIARY, DIAGNOSTIC10 reports
- Exodus 10526CATHETER, BILIARY, DIAGNOSTIC8 reports
- Exodus 10522CATHETER, BILIARY, DIAGNOSTIC4 reports
- Exodus 10143CATHETER, BILIARY, DIAGNOSTIC3 reports
- Exodus 10527CATHETER, BILIARY, DIAGNOSTIC3 reports
- Exodus 10540CATHETER, BILIARY, DIAGNOSTIC3 reports
- Exodus 10412CATHETER, BILIARY, DIAGNOSTIC2 reports
- Exodus 10541CATHETER, BILIARY, DIAGNOSTIC2 reports
- Exodus 10423CATHETER, BILIARY, DIAGNOSTIC1 report
- Exodus 10531CATHETER, BILIARY, DIAGNOSTIC1 report
- Exodus 10562CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Exodus adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMay 7, 2025Crack; Crack
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING AN EXODUS MULTIPURPOSE, DRAINAGE CATHETER, 8F, 25 CM, STD LOOP. IT WAS REPORTED THE PATIENT'S DRAINAGE CATHETER WAS CRACKED, REQUIRING REMOVAL AND REPLACEMENT. THE DRAIN HAD BEEN PLACED IN THE RIGHT POSTERIOR FLANK. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21977282 ↗MalfunctionApr 23, 2025Fracture; Fracture
A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A BILIARY DRAINAGE CATHETER 8F 35 CM STD LOOP W/ RADIOPAQUE MARKER BAND. APPROXIMATELY 3 MONTHS POST PLACEMENT, THE END USER WAS REMOVING THE EXODUS BILIARY CATHETER. WHEN REMOVING THE CATHETER, THE CATHETER FRACTURED AT ALL THE HOLE LOCATIONS. THE DOCTOR WAS ABLE TO REMOVE ALL THE FRAGMENTS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT. ADDITIONAL INFORMATION: IT WAS CONFIRMED THE TIP HAD BEEN PLACED IN THE DUODENUM AND THE PATIENT HAD THEIR GALLBLADDER REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 21891537 ↗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 ↗MalfunctionMar 5, 2024Fracture; Fracture
NEW INFORMATION PROVIDED: CONFIRMATION THAT THE BILIARY CATHETER WAS BEING USED AS AN INTERNAL DRAIN OF BILE INTO THE SMALL INTESTINE. NOTHING WAS BEING INFUSED THROUGH THE CATHETER. CONFIRMATION THAT THE TIP OF THE DRAINAGE CATHETER WAS PLACED IN THE PATIENT'S DUODENUM. CONFIRMATION THE PATIENT DID NOT HAVE ANY RESTRUCTURING OF THEIR GI TRACT DUE TO SURGERY OR TRAUMA, .E.G POST WHIPPLE OR HEPATICOJEJUNOSTOMY.
Patient problems: Foreign Body In Patient
MAUDE report 18836890 ↗MalfunctionMar 5, 2024Fracture; Fracture
DEVICE 2 OF 2: NEW INFORMATION PROVIDED: CONFIRMATION THAT THE BILIARY CATHETER WAS BEING USED AS AN INTERNAL DRAIN OF BILE INTO THE SMALL INTESTINE. NOTHING WAS BEING INFUSED THROUGH THE CATHETER. CONFIRMATION THAT THE TIP OF THE DRAINAGE CATHETER WAS PLACED IN THE PATIENT'S DUODENUM. CONFIRMATION THE PATIENT DID NOT HAVE ANY RESTRUCTURING OF THEIR GI TRACT DUE TO SURGERY OR TRAUMA, .E.G POST WHIPPLE OR HEPATICOJEJUNOSTOMY.
Patient problems: Foreign Body In Patient
MAUDE report 18836886 ↗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 ↗MalfunctionJun 22, 2023Fracture; Fracture
IT WAS REPORTED WHEN REPLACING THE BILIARY CATHETER FROM AN EXODUS DRAINAGE CATH 8F BILIARY PIGTAIL STD - 35CM KIT. AT THE 90-DAY REPLACEMENT PROCEDURE, THE CATHETER DISINTEGRATED AND BROKE INTO SMALLER PIECES. ALL PIECES OF THE CATHETER WERE SUCCESSFULLY REMOVED. THE REPLACEMENT PROCEDURE WAS COMPLETED, USING A BSC BILIARY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17184933 ↗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 ↗MalfunctionAug 23, 2022Fracture; Fracture
AN END USER REPORTED AN ISSUE WITH AN EXODUS DRAINAGE CATHETER. THE DEVICE WAS PLACED THROUGH THE PATIENT'S DUODENUM INTO THE BILIARY SYSTEM. AT A LATER TIME, THE PATIENT WAS BROUGHT IN FOR A PROCEDURE, REQUIRING REMOVAL OF THE DRAIN, AND IT WAS FOUND TO BE BROKEN INTO 3 PIECES. ALL PIECES WERE REMOVED SUCCESSFULLY, FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 15278693 ↗MalfunctionDec 15, 2021Fracture; Fracture
AN END USER REPORTED AN ISSUE WITH AN EXODUS BILIARY DRAINAGE CATHETER 8F 35CM STD LOOP W/ RADIOPAQUE MARKER BAND. PATIENT HAS BEEN RECEIVING BILIARY CATHETER EXCHANGES SINCE (B)(6) 2019 SINCE HE IS NOT A SURGICAL CANDIDATE DUE TO CHRONIC BILIARY STRICTURE AND UNABLE TO UNDERGO ANESTHESIA FOR SURGICAL ALTERNATIVE. THE CATHETER HAD BEEN PLACED IN (B)(6) 2021, AND WHEN ACCESSED ON (B)(6) 2021, IT WAS NOTED THE CATHETER TIP HAD DETACHED INSIDE THE PATIENT. THE FRACTURED 8FR EXODUS BILIARY DRAIN WAS SEEN UPON INITIAL FLUOROSCOPIC EXAM DURING A ROUTINE BILIARY TUBE EXCHANGE. THE TUBE WAS SUCCESSFULLY REMOVED AFTER SHEATH AND SNARE DEVICE USED. IT WAS REPLACED WITH ALTERNATIVE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 13011214 ↗
Other Navilyst Medical, Inc. products
All Navilyst Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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