Becker® 27931Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000333669), received between Aug 9, 2023 and Jan 19, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Nov 1, 2024Open, Classified

   Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

   Z-0661-2025 · Root cause: Under Investigation by firm · Recall details · 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.

• MalfunctionJan 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKING NEAR THE MAIN STOPCOCK. THE DRAIN WAS REPLACED WITH A DIFFERENT DRAIN. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544447 ↗
• MalfunctionJan 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKING NEAR THE MAIN STOPCOCK. THE DRAIN WAS REPLACED WITH A DIFFERENT DRAIN. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544436 ↗
• MalfunctionJan 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKING NEAR THE MAIN STOPCOCK. THE DRAIN WAS REPLACED WITH A DIFFERENT DRAIN. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544424 ↗
• MalfunctionJan 4, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE HAD A CRACK IN THE TUBING NEAR THE PATIENT LINE STOPCOCK. ANOTHER DEVICE OF THE SAME MODEL WAS OPENED TO REPLACE IT, HOWEVER, IT WAS ALSO CRACKED. THE DEVICE WAS REPLACED WITH A DIFFERENT MODEL TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444331 ↗
• MalfunctionJan 4, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE HAD A CRACK IN THE TUBING NEAR THE PATIENT LINE STOPCOCK. ANOTHER DEVICE OF THE SAME MODEL WAS OPENED TO REPLACE IT, HOWEVER, IT WAS ALSO CRACKED. THE DEVICE WAS REPLACED WITH A DIFFERENT MODEL TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444309 ↗
• MalfunctionJan 4, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE HAD A CRACK IN THE TUBING NEAR THE PATIENT LINE STOPCOCK. ANOTHER DEVICE OF THE SAME MODEL WAS OPENED TO REPLACE IT, HOWEVER, IT WAS ALSO CRACKED. THE DEVICE WAS REPLACED WITH A DIFFERENT MODEL TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444282 ↗
• MalfunctionJan 4, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE HAD A CRACK IN THE TUBING NEAR THE PATIENT LINE STOPCOCK. ANOTHER DEVICE OF THE SAME MODEL WAS OPENED TO REPLACE IT, HOWEVER, IT WAS ALSO CRACKED. THE DEVICE WAS REPLACED WITH A DIFFERENT MODEL TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444249 ↗
• MalfunctionDec 11, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS) USED DURING A PROCEDURE. IT WAS REPORTED THAT THE PRODUCT WAS CRACKED AT THE SAMPLE PORT. WHEN THE STOPCOCK WAS OPENED TO TAKE CEREBROSPINAL FLUID (CSF) FROM THE CHAMBER, CSF AND BLOOD LEAKED OUT OF THE STOPCOCK AND APPEARED TO BE CRACKED. NO DELAY OR PATIENT IMPACT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301362 ↗
• MalfunctionNov 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE HOSPITAL USED TWO OF THE DEVICES AND EXPERIENCED A LEAK AT THE STOPCOCK CLOSEST TO THE PATIENT WITH BOTH OF THEM WHILE CONNECTED TO THE PATIENT. THE SITE DISCONNECTED THE TUBING FROM THE PATIENT AND TESTED EACH DEVICE SEPARATELY WITH SALINE AND IDENTIFIED A LEAK AT THE STOPCOCK CLOSEST TO THE PATIENT. A THIRD ONE WAS OPENED AND DID NOT LEAK. THE PRODUCTS WERE USED IN THE EMERGENCY ROOM. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147922 ↗
• MalfunctionNov 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE HOSPITAL USED TWO OF THE DEVICES AND EXPERIENCED A LEAK AT THE STOPCOCK CLOSEST TO THE PATIENT WITH BOTH OF THEM WHILE CONNECTED TO THE PATIENT. THE SITE DISCONNECTED THE TUBING FROM THE PATIENT AND TESTED EACH DEVICE SEPARATELY WITH SALINE AND IDENTIFIED A LEAK AT THE STOPCOCK CLOSEST TO THE PATIENT. A THIRD ONE WAS OPENED AND DID NOT LEAK. THE PRODUCTS WERE USED IN THE EMERGENCY ROOM. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147914 ↗
• MalfunctionNov 13, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHILE ONE OF THE NEUROSURGERY NURSE PRACTITIONERS WAS ADMINISTERING INTRATHECAL MILRINONE, THEY NOTICED AIR BUBBLES IN THE TUBING AND WHEN INVESTIGATING FURTHER, IT WAS NOTED THAT THERE WAS A CRACK IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18119800 ↗
• MalfunctionOct 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT FLUID LEAKED AT THE CONNECTION TO THE 3-WAY STOPCOCK WHICH WAS ONE THAT CANNOT BE MANIPULATED. IT WAS ATTEMPTED TO BE TIGHTENED WITHOUT RESOLUTION. THE REPORTED EVENT RESULTED IN A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904840 ↗
• MalfunctionOct 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT FLUID LEAKED AT THE CONNECTION TO THE 3-WAY STOPCOCK WHICH WAS ONE THAT CANNOT BE MANIPULATED. IT WAS ATTEMPTED TO BE TIGHTENED WITHOUT RESOLUTION. THE REPORTED EVENT RESULTED IN A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904801 ↗
• MalfunctionAug 9, 2023Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE TUBING NEAR THE MAIN STOP COCK DISENGAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17492143 ↗