X-Stream 5551000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741010118), received between Apr 4, 2018 and Mar 4, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (11 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 14, 2020Thermal Decomposition of Device; Failure to Prime; Thermal Decomposition of Device; Failure to Prime

  IT WAS REPORTED THAT IN PREPARATION FOR A PROCEDURE WHEN ATTEMPTING TO PRIME THE X-STREAM CONTROLLER, ONCE THE IRRIGATION BUTTON WAS PRESSED, THE PRIME LIGHT ILLUMINATES HOWEVER THE CONTROLLER WILL NOT DO ANYTHING PAST THE PRIME STAGE. ANOTHER CONTROLLER WAS USED IN THE CASE WITH THE TUBING SET. THERE WAS NO PATIENT INJURY OR INTERVENTION AS A RESULT OF THE PROBLEM EXPERIENCED. THE SUBJECT PRODUCT WAS RETURNED AND EVALUATION IDENTIFIED THAT SOME INTERNAL COMPONENTS HAD HEAT DAMAGE. THERE WAS NO REPORT OF A SHORT CIRCUIT, SMOKE, OR FLAME HAVING OCCURRED DURING USE OF THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 9710919 ↗
• MalfunctionOct 29, 2019Thermal Decomposition of Device; Failure to Prime; Thermal Decomposition of Device; Failure to Prime

  IT WAS REPORTED PER THE CUSTOMER CONTACT THAT DURING THE SET UP OF A PROCEDURE BEFORE USE THE X-STREAM CONTROLLER WOULD NOT ALLOW FOR ANY IRRIGATION FLUID TO FLOW INTO THE TUBING SET. ANOTHER CONTROLLER WAS USED IN THE CASE, WITH THE TUBING SET. THERE WAS NO PATIENT INJURY OR INTERVENTION AS A RESULT OF THE PROBLEM EXPERIENCED. THE SUBJECT PRODUCT WAS RETURNED AND EVALUATION IDENTIFIED THAT SOME INTERNAL COMPONENTS HAD HEAT DAMAGE. THERE WAS NO REPORT OF A SHORT CIRCUIT, SMOKE, OR FLAME HAVING OCCURRED DURING USE OF THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 9251620 ↗
• MalfunctionSep 16, 2019Smoking; Smoking

  PER MEDWATCH# 5088440 THAT DURING A SURGICAL PROCEDURE, THE SUCTION IRRIGATOR MACHINE STARTED TO SMOKE. MACHINE STOPPED AND REMOVED. MACHINE SENT FOR EVALUATION. UNK. ETIOLOGY OF CAUSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9071111 ↗
• MalfunctionJun 28, 2019Thermal Decomposition of Device; Failure to Pump; Thermal Decomposition of Device; Failure to Pump

  IT WAS REPORTED PER THE CUSTOMER CONTACT THAT THE X-STREAM CONTROLLER WAS NOT WORKING, THE UNIT WOULD NOT POWER ON. THERE WAS NO PATIENT INJURY OR INTERVENTION REPORTED. THE SUBJECT PRODUCT WAS RETURNED AND EVALUATION IDENTIFIED THAT SOME INTERNAL COMPONENTS HAD HEAT DAMAGE WITH EVIDENCE OF INTERNAL COMBUSTION HAVING OCCURRED. THERE WAS NO REPORT OF A SHORT CIRCUIT, SMOKE, OR FLAME HAVING OCCURRED DURING USE OF THE DEVICE. IT IS NOT KNOWN WHEN THE INTERNAL DAMAGE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744666 ↗
• MalfunctionDec 19, 2018Thermal Decomposition of Device; Failure to Pump; Use of Device Problem; Thermal Decomposition of Device; Failure to Pump; Use of Device Problem

  IT WAS REPORTED THAT DURING SET UP OF AN UNSPECIFIED PROCEDURE, THE OPERATING ROOM (OR) STAFF NOTICED THE X-STREAM CONTROLLER WOULD NOT FUNCTION IN THE HI OR LO SETTING AND THE LED LIGHTS WOULD NOT ILLUMINATE. THE OR STAFF USED ANOTHER CONTROLLER FOR THE CASE. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS SENT TO THE BIOMED DEPT. WITH THE SAME RESULTS. THE SUBJECT PRODUCT WAS RETURNED TO DAVOL FOR EVALUATION AND THE EVALUATION IDENTIFIED THAT SOME INTERNAL COMPONENTS HAD HEAT DAMAGE WITH EVIDENCE OF INTERNAL COMBUSTION HAVING OCCURRED. THERE WAS NO REPORT OF A SHORT CIRCUIT, SMOKE, OR FLAME HAVING OCCURRED DURING USE OF THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 8182201 ↗
• MalfunctionAug 21, 2018Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up

  IT WAS REPORTED PER THE CUSTOMER CONTACT THAT THE X-STREAM CONTROLLER DID NOT POWER ON DURING SET UP OF A CASE. THERE WAS NO PATIENT INVOLVEMENT. THE SUBJECT PRODUCT WAS RETURNED AND EVALUATION IDENTIFIED THAT SOME INTERNAL COMPONENTS HAD HEAT DAMAGE WITH EVIDENCE OF INTERNAL COMBUSTION HAVING OCCURRED. THERE WAS NO REPORT OF A SHORT CIRCUIT, SMOKE, OR FLAME HAVING OCCURRED DURING USE OF THE DEVICE. IT IS NOT KNOWN WHEN THE INTERNAL DAMAGE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 7802473 ↗
• MalfunctionJun 21, 2018Thermal Decomposition of Device; Failure to Power Up; Use of Device Problem; Thermal Decomposition of Device; Failure to Power Up; Use of Device Problem

  IT WAS REPORTED PER THE CUSTOMER CONTACT THAT DURING TESTING, THE X-STREAM CONTROLLER WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT. THE SUBJECT PRODUCT WAS RETURNED AND EVALUATION IDENTIFIED THAT SOME INTERNAL COMPONENTS HAD HEAT DAMAGE WITH EVIDENCE OF INTERNAL COMBUSTION HAVING OCCURRED. THERE WAS NO REPORT OF A SHORT CIRCUIT, SMOKE, OR FLAME HAVING OCCURRED DURING USE OF THE DEVICE. IT IS NOT KNOWN WHEN THE INTERNAL DAMAGE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 7625222 ↗
• MalfunctionApr 4, 2018Thermal Decomposition of Device; Use of Device Problem; Thermal Decomposition of Device; Use of Device Problem

  IT WAS REPORTED THAT DURING SET UP OF A PROCEDURE AFTER INSERTING AN X-STREAM TUBING SET INTO AN X-STREAM CONTROLLER, THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT. THE SUBJECT PRODUCT WAS RETURNED AND EVALUATION IDENTIFIED THAT SOME INTERNAL COMPONENTS HAD HEAT DAMAGE WITH EVIDENCE OF INTERNAL COMBUSTION HAVING OCCURRED. IT WAS REPORTED BY THE BIOMED CONTACT THAT IT WAS POSSIBLE THE UNIT WAS DROPPED OR DAMAGED IN USE. THE STAFF WILL CHANGE THEM ON THE POLE AND THEY CAN SEE SOME TRAUMA BETWEEN CASES. THERE WAS NO REPORT OF A SHORT CIRCUIT, SMOKE, OR FLAME HAVING OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 7395286 ↗