X-Stream 5552003Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741010101), received between May 31, 2017 and Nov 3, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• MalfunctionNov 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A SET UP OF THE PROCEDURE IN THE OPERATING ROOM ON (B)(6) 2020, THE X-STREAM LAPAROSCOPIC IRRIGATION TUBING SET WITH NEZHAT DORSEY TRUMPET VALVE LEAKED AT PLASTIC RESERVOIR. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS NOT USED ON PATIENT; AS SUCH, THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10813714 ↗
• MalfunctionMay 31, 2017Unsealed Device Packaging; Device Contamination with Chemical or Other Material; Unsealed Device Packaging; Device Contamination with Chemical or Other Material

  INFORMATION AS REPORTED BY THE CUSTOMER CONTACT: A PACKAGE OF DAVOL X-STREAM TUBING WAS BROUGHT TO ME WITH A HAIR STERILIZED IN THE PACKAGE. THE HAIR IS ACTUALLY CAUGHT IN THE SEAL OF THE PACKAGE, SO IT IS BOTH INSIDE AND OUTSIDE OF THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 6600867 ↗