X-StreamRecalls & reported problems across all models
Davol Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one X-Stream model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of X-Stream by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between May 31, 2017 and Mar 4, 2022 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (11 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
X-Stream recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 27, 2022Open, Classified
The device may potentially cause a fire, leading to a safety risk.
Z-1457-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported X-Stream problems
Device problems
- Thermal Decomposition of Device11
- Fluid/Blood Leak8
- Detachment of Device or Device Component5
- Device Contamination with Chemical or Other Material5
- Use of Device Problem3
- Break2
- Failure to Power Up2
- Failure to Prime2
Patient problems
- No Patient Involvement13
- No Consequences Or Impact To Patient12
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information1
X-Stream models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- X-Stream 5551000Laparoscope, general & plastic surgery1 recall14 reports
- X-Stream 5552002LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)10 reports
- X-Stream 5552003LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)7 reports
- X-Stream 5552001Laparoscope, general & plastic surgery3 reports
Recent X-Stream adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2022Thermal Decomposition of Device; Arcing; Thermal Decomposition of Device; Arcing
AS REPORTED, AT THE END OF A CASE USING THE BARD/DAVOL X-STREAM IRRIGATION CONTROLLER PUMP, THE CONTACT WAS TRYING TO DETERMINE WHAT CAUSED ONE OF THE OPERATING ROOMS ELECTRICAL CIRCUIT BREAKERS TO TRIP. AS REPORTED, THE LOCATION OF THE POWER CORD WAS MOVED TO A FUNCTIONAL ELECTRICAL OUTLET AND AT THAT MOMENT AN ELECTRICAL ARC FLASHED; MELTED POWER CORD AND AC INPUT PARTS WERE NOTED. AS REPORTED, IS UNKNOWN IF FLUID WAS LEAKING FROM DEVICE BEFORE THE ARC. AS REPORTED, THE POWER CORD USED WAS THE SAME AS THAT SUPPLIED WITH THE UNIT AND WAS PLUGGED INTO A HOSPITAL GRADE AC OUTLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13666659 ↗MalfunctionNov 17, 2021Break; Break
AS REPORTED, DURING A ROBOTIC HYSTERECTOMY PROCEDURE, THE QD ADAPTER OF THE BARD/DAVOL X-STREAM TUBING SET ON THE ND TRUMPET VALVE BROKE OFF DURING USE. IT WAS REPORTED THAT THE PIECE THAT BROKE OFF WAS RETRIEVED AND THE OR STAFF USED A DIFFERENT DEVICE TO FINISH THE CASE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12828346 ↗MalfunctionNov 10, 2021Thermal Decomposition of Device; Thermal Decomposition of Device
AS REPORTED, DURING SET-UP OF A PROCEDURE, THE BARD/DAVOL X-STREAM CONTROLLER WOULD NOT POWER ON. AS REPORTED, THE DEVICE WAS TESTED BY THE BIOMED WHO CONFIRMED THE DEVICE HAD NO POWER AFTER INSERTING A TUBING CASSETTE USED SPECIFICALLY FOR TESTING. IT IS REPORTED THAT THE FUSES WERE GOOD, VOID SEALS ARE INTACT AND THERE WAS NO DAMAGE NOTED TO THE DEVICE. AS REPORTED, THERE WAS NO PATIENT INVOLVEMENT. SAMPLE EVALUATION IDENTIFIED HEAT DAMAGE TO INTERNAL COMPONENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12785860 ↗MalfunctionNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE FOLLOWING WAS REPORTED TO BD BY THE FDA VIA MEDWATCH 3500A FORM # (B)(4): THE BARD/DAVOL X-STREAM LAPAROSCOPIC TUBING: THE CAP (PLUG) OF THE SUCTION IRRIGATOR FELL OFF. OCCURRED TWICE. ADDITIONAL INFORMATION PROVIDED IN FOLLOW UP: IT WAS REPORTED THAT ON (B)(6) 2021, TWO X-STREAM LAPAROSCOPIC TUBING SETS WERE USED IN THE SAME CASE AND THE CAP (PLUG) FELL OFF BOTH DEVICES. THE CAPS (PLUGS) WERE RETRIEVED AND THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12743491 ↗MalfunctionNov 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE FOLLOWING WAS REPORTED TO BD BY THE FDA VIA MEDWATCH 3500A FORM # (B)(4): THE BARD/DAVOL X-STREAM LAPAROSCOPIC TUBING: THE CAP (PLUG) OF THE SUCTION IRRIGATOR FELL OFF. OCCURRED TWICE. ADDITIONAL INFORMATION PROVIDED IN FOLLOW UP: IT WAS REPORTED THAT ON 15-SEP-2021, TWO X-STREAM LAPAROSCOPIC TUBING SETS WERE USED IN THE SAME CASE AND THE CAP (PLUG) FELL OFF BOTH DEVICES. THE CAPS (PLUGS) WERE RETRIEVED AND THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12740625 ↗MalfunctionSep 29, 2021Device Slipped
X-STREAM LAPAROSCOPIC IRRIGATION TUBING: THE CAP OF THE SUCTION IRRIGATOR FELL OFF. OCCURRED TWICE.
Patient problems: Insufficient Information
MAUDE report 12546227 ↗MalfunctionJul 7, 2021Thermal Decomposition of Device; Fire; Thermal Decomposition of Device; Fire
AS REPORTED, THE BARD/DAVOL X-STREAM IRRIGATION CONTROLLER WAS FOUND TO HAVE CAUGHT FIRE IN THE OR WHEN THERE WAS NO STAFF PRESENT (OFF HOURS 9:00 P.M. - 2:00 A.M.) ON (B)(6) 2021. THE FIRE ALARM WENT OFF AND THE SECURITY WAS ABLE TO SECURE THE SCENE. THERE WAS NO HARM TO ANY PERSONS AND NO ADDITIONAL DAMAGE TO ANY OF THE SURROUNDING MATERIALS IN THE OR. IT WAS REPORTED IT LOOKED LIKE THE ELECTRICAL CONNECTOR OVERHEATED, BURNED AND ALSO SCORCHED THE POWER PANEL ON THE BACK OF THE DEVICE. AS REPORTED, THE POWER CORD IS ALWAYS CONNECTED TO THE WALL SOURCE (HOSPITAL GRADE AC OUTLET) AND NEVER UNPLUGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12129552 ↗MalfunctionApr 26, 2021Smoking; Smoking
AS REPORTED, DURING A PROCEDURE ON (B)(6) 2021 WHILE USING A BARD/DAVOL X-STREAM CONTROLLER, THE OR STAFF NOTICED AN ODOR, LIKE SMOKE EMISSION FROM THE CONTROLLER. NO FIRE WAS REPORTED, MORE LIKE AN ELECTRICAL ODOR. AS REPORTED, THE OR REMOVED THE CONTROLLER AND REPLACED IT WITH ANOTHER CONTROLLER TO COMPLETE THE CASE. AS REPORTED, THERE WAS NO PATIENT OR USER HARM AND THE CONTROLLER WAS GIVEN TO THE BIOMED DEPT. AS REPORTED, BIOMED TESTED THE DEVICE AND DID NOT SMELL ANY SMOKE; HOWEVER, NOTED THE LO AND HI LEDS WOULD NOT ILLUMINATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11723622 ↗MalfunctionMar 1, 2021Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED, THE PACKAGING OF THE BARD/DAVOL X-STREAM TUBING SET ND HANDLE W/O TIP WAS NOTED TO BE CREASED AND FOLDED ON 08-FEB-2021. IT IS ALSO REPORTED THAT THE PACKAGING WAS NON-STERILE, RUPTURING THE STERILITY BARRIER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11396211 ↗MalfunctionFeb 4, 2021Thermal Decomposition of Device; Device Remains Activated; Thermal Decomposition of Device; Device Remains Activated
AS REPORTED, DURING A PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL X-STREAM CONTROLLER WAS CONTINUOUSLY RUNNING WITHOUT SHUT OFF. THE OPERATING ROOM STAFF REPLACED THE CONTROLLER TO COMPLETE THE CASE. AS REPORTED, ONE TUBING SET WAS USED WITH THE CONTROLLER AND THE DEVICE WAS NOT TESTED. AS REPORTED, THERE IS NO PHYSICAL DAMAGE, THE VOID SEAL IS NOT BROKEN AND THE STAFF IS FAMILIAR WITH THE USE OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. SAMPLE EVALUATION IDENTIFIED HEAT DAMAGE TO INTERNAL COMPONENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11281943 ↗MalfunctionFeb 1, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
AS REPORTED, DURING A PROCEDURE ON (B)(6) 2021, THE SUCTION TIP OF THE BARD/DAVOL X-STREAM LAPAROSCOPIC IRRIGATION TUBING SET WITH NEZHAT-DORSEY TRUMPET VALVE FELL OFF AND IRRIGATION FLUID LEAKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11257531 ↗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 ↗MalfunctionDec 9, 2020Corroded; Corroded
AS REPORTED, DURING THE SET UP OF AN UNKNOWN PROCEDURE, THE OR STAFF NOTED THE BACK OF THE X-STREAM CONTROLLER POWER CORD PLUG WAS CHARRED/CORRODED AND BLACK IN APPEARANCE. IT WAS ALSO REPORTED THAT THE BIOMED TECH CHECKED THE FUSES AND STATED THAT THEY APPEARED TO BE FINE WITHOUT ANY ISSUE.
Patient problems: No Patient Involvement
MAUDE report 10975376 ↗
Other Davol Inc. products
All Davol 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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