Becker® 27779 (UDI 00763000333591)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000333591), received between Sep 9, 2022 and Jun 5, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING A ROUTINE CHECK UP OF THE PATIENT'S DRAINAGE SYSTEM, A LEAKAGE OF CEREBROSPINAL FLUID IN THE STOPCOCK WAS DISCOVERED. THE DRAINAGE SYSTEM WAS CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153963 ↗
• MalfunctionMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STAFF IN THE ROOM DISCOVERED THAT THE COLLECTION CONTAINER FOR CEREBROSPINAL FLUID WAS EMPTY EVEN THOUGH NONE OF THE STAFF HAD EMPTIED IT. BOTH CLAMPS WERE STILL CLOSED. A TEST WAS PERFORMED ON THE SYSTEM TO SEE WHAT WAS WRONG AND FOUND THAT THE CLAMPS DID NOT HOLD TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381543 ↗
• MalfunctionMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STAFF IN THE ROOM DISCOVERED THAT THE COLLECTION CONTAINER FOR CEREBROSPINAL FLUID WAS EMPTY EVEN THOUGH NONE OF THE STAFF HAD EMPTIED IT. BOTH CLAMPS WERE STILL CLOSED. A TEST WAS PERFORMED ON THE SYSTEM TO SEE WHAT WAS WRONG AND FOUND THAT THE CLAMPS DID NOT HOLD TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381529 ↗
• MalfunctionApr 9, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE TUBING SPONTANEOUSLY DISCONNECTED WHEN PRIMING THE SYSTEM. THE DEVICE 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 19069679 ↗
• MalfunctionApr 3, 2024Fluid/Blood Leak; Infusion or Flow Problem; Fluid/Blood Leak; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SYSTEM WITH CEREBROSPINAL FLUID (CSF) IN THE TUBING DRAINED INTO THE COLLECTION BAG BELOW THE 2 CLAMPS WHICH WERE CLOSED IN THE MORNING AS WELL AS CSF LEAKING FROM THE TUBING BELOW THE GRADUATED CYLINDER. THE TUBING FULLY DRAINED AND DISCUSSED WITH THE NURSE ABOUT CLOSELY WATCHING IF IT REOCCURRED. IN THE EVENING, THE SAME ISSUE OCCURRED AND QUESTIONED IF A PRODUCT ISSUE WAS WITH THE CLAMPS AS THEY WERE NOT FULLY OCCLUDING THE DRAINAGE. A BLUE PLASTIC CLAMP WAS APPLIED TO PREVENT ANY UNACCOUNTED CSF THAT MAY BE DRAINING INTO THE BAG INADVERTENTLY AND NOT BEING ACCOUNTED FOR IN THE HOURLY DRAINAGE OF THIS DEVICE. HOWEVER, THE DEVICE WAS REPLACED WITH ANOTHER ONE OF THE SAME UNIT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031835 ↗
• MalfunctionMar 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE SYSTEM. IT WAS REPORTED THAT THE SYSTEM WAS LEAKING BELOW THE COLLECTION CHAMBER. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874001 ↗
• MalfunctionJul 24, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE DEVICE DISCONNECTED FROM THE REST OF THE SYSTEM WHICH RESULTED IN CSF DRAINAGE. THE DEVICE DID HAVE CONTACT WITH THE PATIENT. THERE WAS NO REPORTED PATIENT HARM. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A DIFFERENT EVD SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17380759 ↗
• MalfunctionApr 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2023. THERE WERE NO PROBLEMS WITH THE DEVICE AT THE TIME AND NO LEAKAGE DETECTED. SUDDENLY AT THE ICU THE NIGHT OF (B)(6) BETWEEN 4AM-7AM, A LEAKAGE WAS DETECTED FROM THE RESERVOIR. IT WAS CONFIRMED THAT THE LEAK WAS COMING FROM THE GRADUATED CYLINDER. IT WAS WET ON THE FLOOR CLOSE TO THE PATIENT BED. THERE WAS NO INJURY TO PATIENT OUTCOME, BECAUSE THE PATIENT WAS STABLE IN HEART RATE AND NO COUGHING DURING THE TIME THE DEVICE DID NOT MONITOR CORRECTLY. THERE WAS 20 MINUTES WITH NO INTRACRANIAL PRESSURE(ICP) MONITORING. THE NURSE CALLED THE DOCTOR. THE DRAINAGE WAS CLOSEDON ORDER OF THE NEUROSURGEON. THE EDMS WAS SWITCHED OUT AT THE ICU FOR CORRECT MONITORING OF ICP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751793 ↗
• MalfunctionSep 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EDMS BECKER DEVICE. IT WAS REPORTED THAT WHEN THE SITE NEEDED PRESSURE MEASUREMENTS THE NURSE NOTICED A LEAK IN THE STOP COCK. THE BECKER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE ISSUE SEEMED TO BE THE PART ATTACHED ON THE PLASTIC OF THE PATIENT LINE WHICH WAS HAVING THE LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15404532 ↗
• MalfunctionSep 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE SYSTEM. THE SYSTEM WAS PLACED ON HIGH PRESSURE IN THE SPINE/LUMBAR AFTER AN AORTIC ABDOMINAL SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. WHEN NEED OF PRESSURE MEASUREMENTS IN THE SPINE/LUMBAR THE HEALTH CARE PROFESSIONAL SAW LEAKAGE IN THE STOP-COOK. THEY CHANGE THE SYSTEM TO A NEW ONE. THE PART THAT WAS LEAKING WAS THE PART ATTACHED ON THE PLASTIC/PAPER OF THE PATIENT LINE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403096 ↗
• MalfunctionSep 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A BECKER DEVICE. IT WAS REPORTED THAT THE SYSTEM WAS EVACUATED OF BUBBLES BY A SYRINGE WITH LIQUID DIRECT FROM THE PATIENT LINE. AND THE REST WAS FILLED UP AGAIN WITH NACL TO EVACUATE THE BUBBLES. THE BUBBLES TURNED UP AGAIN. THE NURSE DID CONTACT THE SURGEON AND GOT THE ORDER TO CHANGE TO A NEW DEVICE. IT SEEMED TO BE THE FIRST PART OF THE PATIENT LINE WHICH WAS HAVING A LEAK. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402436 ↗
• MalfunctionSep 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A BECKER DEVICE. IT WAS REPORTED THAT THE SYSTEM WAS EVACUATED OF BUBBLES BY A SYRINGE WITH LIQUOR DIRECT FROM THE PATIENT LINE. AND THE REST WAS FILLED UP AGAIN WITH NACL TO EVACUATE THE BUBBLES. THE BUBBLES TURNED UP AGAIN. THE NURSE DID CONTACT THE SURGEON AND GOT THE ORDER TO CHANGE TO A NEW DEVICE. IT SEEMED TO BE THE FIRST PART OF THE PATIENT LINE WHICH WAS HAVING A LEAK. THE ISSUE WAS FOUND ABOVE THE DRAINAGE BAG. IT WAS SOMEWHERE BETWEEN THE PATIENT AND 3-WAYS STOP-COCK ATTACHED ON THE PLASTIC. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394935 ↗
• MalfunctionSep 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A BECKER SYSTEM. IT WAS REPORTED THAT IT WAS PLACED ON HIGH PRESSURE IN THE BRAIN. THE PROCEDURE WAS COMPLETED NORMALLY. WHEN NEED OF PRESSURE MEASUREMENTS THE HEALTH CARE PROFESSIONAL SAW LEAKAGE IN THE STOP-COCK. THE HCP ORDER TO CHANGE TO A NEW BECKER SYSTEM. IT WAS THE PART ATTACHED ON THE PLASTIC/PAPER OF THE PATIENT LINE WHICH IS HAVING A LEAKAGE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393355 ↗