Exodus 10541Recalls & reported problems
Navilyst Medical, Inc. · Array Multipurpose Drainage Catheter 10F x 25cm with Tight Pigtail · Class 2
All models of Exodus (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965105410), received between Mar 13, 2020 and Jan 31, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (2 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
Device problems
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2021Crack; Crack
A RADIOLOGY TECHNICIAN REPORTED AN ISSUE WITH AN INDWELLING EXODUS MULTIPURPOSE 14F 25 CM DRAINAGE CATHETER. IT WAS REPORTED THAT A CRACK WAS DISCOVERED IN THE HUB. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM 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 11256408 ↗MalfunctionMar 13, 2020Crack; Crack
AS REPORTED, A PATIENT HAD A CRACKED HUB ON OUR EXODUS 10F MULTIPURPOSE DRAINAGE CATHETER. THIS WAS DISCOVERED ON (B)(6) 2020. THIS WAS THE SAME PATIENT AND A SECOND CRACKED HUB, BUT A DIFFERENT SIZE DRAIN. 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 9829113 ↗
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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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