Becker® 25120Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000333430), received between May 19, 2022 and Sep 8, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORY SYSTEM. IT WAS REPORTED THAT THE DRAIN TUBING BROKE OFF THE Y PORT ON THE PRESSURE TUBING CONNECTED TO THE DRAIN. THE 3-WAY STOP COCK PROXIMAL TO PATIENT WAS IMMEDIATELY CLOSED TO THE PATIENT, AND THE DRAIN CLAMPED. A NEW DRAIN SET UP WAS OBTAINED AND SET UP, CONNECTED TO PATIENT, DRAIN RELEVELED AND ZEROED WITH GOOD WAVE FORM DISPLAYED ON THE MONITOR, ICP [INTRACRANIAL PRESSURE] 14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992485 ↗
• MalfunctionSep 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHILE USING THE SYSTEM, THE DOCTOR NOTICED A LEAK OF CEREBROSPINAL FLUID FROM THE PATIENT LINE AT THE VALVE LEVEL. THE SYSTEM WAS REPLACED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135401 ↗
• MalfunctionSep 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHILE USING THE SYSTEM, THE DOCTOR NOTICED A LEAK OF CEREBROSPINAL FLUID FROM THE PATIENT LINE AT THE VALVE LEVEL. THE SYSTEM WAS REPLACED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135179 ↗
• MalfunctionJun 26, 2024Break; Fluid/Blood Leak; Fracture; Insufficient Device Problem Information; Break; Fluid/Blood Leak; Fracture; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS A FAILURE OF THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613820 ↗
• MalfunctionMar 27, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE COLLECTION COLLECTION CHAMBER AND THE TUBING BELOW THAT WAS CLAMPED WAS NOTED TO BE LEAKING. ON FURTHER INSPECTION IT APPEARED THAT THE TUBING HAD SOME CRACKS IN IT CAUSING THE LEAK. THE MANUFACTURER REPRESENTATIVE WAS INFORMED THAT THE TUBING IN THAT LOCATION OF THE DEVICE FELT RIGID. THE ONE THAT WAS USED TO REPLACE THE ORIGINAL ONE HAD SOFTER PLIABLE TUBING AND APPEARED TO BE FUNCTIONING APPROPRIATELY. THERE WAS A PROCEDURE DELAY OF 15 MINUTES. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988365 ↗
• MalfunctionDec 1, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2023 REGISTERING PRESSURE READING. THE SYSTEM WAS LEAKING AND HAD COME APART BETWEEN THE COLLECTION CHAMBER AND DRAINAGE BAG. THE SYSTEM WAS CHANGED TO ANOTHER SYSTEM. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246265 ↗
• MalfunctionOct 31, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE SYSTEM WAS IN USE ON (B)(6) 2023, AND THEN ON (B)(6) 2023, THE SYSTEM WAS BROKEN WHERE THE BREAKAGE OF THE DRAINAGE WAS AT THE SET AT THE HEIGHT OF THE CLAMP DOWNSTREAM OF THE COLLECTION WELL. THE DEVICE WAS CHANGED FOR ANOTHER ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038183 ↗
• MalfunctionOct 25, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS BREAKAGE OF THE DRAINAGE SET AT THE HEIGHT OF THE TAP PROXIMAL TO THE CATHETER CONNECTION. THE SYSTEM WAS REPLACED. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004909 ↗
• MalfunctionOct 25, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS BREAKAGE OF THE DRAINAGE SET AT THE HEIGHT OF THE CLAMP DOWNSTREAM OF THE COLLECTION WELL. THE SYSTEM WAS REPLACED. THERE WAS A PROCEDURE DELAY OF 60 MINUTES. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004418 ↗
• MalfunctionOct 23, 2023Break; Fracture; Break; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A PROCEDURE DELAY OF 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986278 ↗
• MalfunctionMay 10, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT AT 18:06 IN THE EVENING, THE DOCTOR REPORTED THAT THE DEVICE WAS NOT DRAINING CSF. THE REPRESENTATIVE ASKED IF THE SYSTEM WAS PRIMED BEFORE CONNECTING TO THE PATIENT LINE AND THE DOCTOR REPLIED YES. THEY QUESTIONED IF IT WAS PRIMED SEQUENTIALLY FOLLOWING THE MANUALS RECOMMENDATIONS AND REVIEWED THE STEPS. THE DOCTOR CONFIRMED THAT THE SYSTEM WAS PRIMED CORRECTLY. THE DOCTOR STOPPED USING THIS DEVICE AND IT WAS REPLACED WITH A DIFFERENT SYSTEM, AND DID SO AT THE PATIENT'S BEDSIDE IN THE PICU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16902427 ↗
• MalfunctionNov 21, 2022Break; Disconnection; Fracture; Break; Disconnection; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS) USED DURING A PROCEDURE. IT WAS REPORTED THAT THERE WAS A RUPTURE WITH DETACHMENT OF THE DEVICE UNDER THE LIQUID COLLECTION PUMP. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THE ISSUE WAS CONFIRMED TO HAVE OCCURRED ABOVE THE DRAINAGE BAG. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS IS THE SECOND OCCURRENCE OF THIS ISSUE. THE CAUSE OF THE ISSUE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834183 ↗
• MalfunctionNov 16, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL MONITORING DEVICE. IT WAS REPORTED THAT THERE WAS A RUPTURE WITH DETACHMENT OF THE DEVICE UNDER THE LIQUID COLLECTION SUMP. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15806099 ↗
• MalfunctionSep 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A BECKER DEVICE. IT WAS REPORTED THAT THERE CEREBROSPINAL FLUID (CSF) LEAKAGE FROM THE CSF COLLECTION WELL. THE DEVICE WAS CHANGED FOR ANOTHER DEVICE AND THE ISSUE WAS RESOLVED WITH NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476756 ↗
• MalfunctionMay 19, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE SYSTEM. IT WAS REPORTED THAT THERE WAS A BREAKAGE OF THE DRAINAGE SYSTEM OF THE CSF DERIVATION UNDER THE COLLECTION CHAMBER, UNDER THE CLAMP WITH CONSEQUENT CONSEQUENT CREATION OF AN OPEN CIRCUIT. IT WAS NECESSARY TO REPLACE THE OPEN CIRCUIT WITH A NEW CLOSED SYSTEM. THE PROCEDURE WAS COMPLETED WITH A BACK UP PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434279 ↗