X-Stream 5552001Recalls & reported problems
Davol Inc. · X-Stream Laparoscopic Irrigation Tubing Set with SmokEvac Trumpet Valve, and Cojoined Suction/Irrigation Tubing, without Probe Tip · Class 2
All models of X-Stream (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741010088), received between Dec 17, 2020 and Jan 6, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
Device problems
- Fluid/Blood Leak3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2020, THE LAPAROSCOPIC IRRIGATION X-STREAM TUBING SET W/ ND SMOKEVAC TRUMPET VALVE WAS LEAKING FROM THE PUMP CONNECTOR WHEN CONNECTED TO A NORMAL SALINE (NS) BAG. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11122827 ↗MalfunctionDec 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, ON (B)(6) 2020 DURING THE INSTALLATION OF STERILE WATER IN X-STREAM TUBING SET W/ ND SMOKEVAC TRUMPET VALVE, THERE WAS LEAKAGE IN THE TUBING SET AT THE BOTTOM OF THE CASSETTE. THE EVENT HAPPENED TWICE. THERE WAS NO REPORTED PATIENT INJURY BUT THERE WAS A DELAY IN STARTING THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11027580 ↗MalfunctionDec 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, ON (B)(6) 2020 DURING THE INSTALLATION OF STERILE WATER IN X-STREAM TUBING SET W/ ND SMOKEVAC TRUMPET VALVE, THERE WAS LEAKAGE IN THE TUBING SET AT THE BOTTOM OF THE CASSETTE. THE EVENT HAPPENED TWICE. THERE WAS NO REPORTED PATIENT INJURY BUT THERE WAS A DELAY IN STARTING THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11027469 ↗
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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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