Becker® 46128 (UDI 00763000333676)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00763000333676), received between Aug 23, 2021 and Jan 13, 2026 — classified as 4 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PRODUCT HAD A LEAKAGE ISSUE UNDER THE CYLINDRIC CHAMBER AND COULD NOT PROVIDE ACCURATE MEASUREMENT RESULTS. AFTER DETECTING THE ABNORMALITY, THE HOSPITAL REPLACED IT WITH A NEW PRODUCT TO CONTINUE TREATMENT. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053581 ↗
• MalfunctionMay 27, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBING WAS CRACKED AND LEAKING. A NEW DRAINAGE SYSTEM WAS USED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089888 ↗
• MalfunctionFeb 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED WHEN CHANGING THE BAG ON THE SYSTEM, THE NURSE DISCOVERED A LEAK AT THE BASE OF THE BURETTE WHEN UNCLAMPING TO DRAIN THE BURETTE. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312197 ↗
• MalfunctionDec 9, 2024

  STOPCOCK ON EXTERNAL VENTRICULAR DRAIN (EVD) NOTED TO BE CRACKED AND LEAKING WHEN TURNED TO CHECK INTERCRANIAL PRESSURE (ICP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20877866 ↗
• MalfunctionNov 26, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT'S DRAIN SYSTEMS FAILED CAUSING CEREBROSPINAL FLUID TO DRAIN DIRECTLY ON THE FLOOR. THE TUBING CONNECTED TO THE BOTTOM OF THE BURETTE WAS PARTIALLY DISCONNECTED. THE PRODUCT WAS REPLACED WITH ANOTHER DRAIN. THE TUBING OF THE SECOND DRAIN DISCONNECTED ENTIRELY FROM THE BOTTOM OF THE BURETTE BUT WAS REATTACHED BY THE NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786936 ↗
• MalfunctionJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ENTIRE DRAINAGE SYSTEM WAS REPLACED. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793977 ↗
• MalfunctionJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE WAS LEAKING CER EBROSPINAL FLUID BELOW THE CLAMP RESULTING IN INACCURATE MEASUREMENTS AND INCREASING RISK OF INFECTION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793726 ↗
• MalfunctionMay 16, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON MAY 7, 2024, THE CONNECTING TUBE OF THE MEASURE CYLINDER FELL OFF. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333288 ↗
• MalfunctionMay 16, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2024, THE UPPER AND LOWER TUBE CLAMPS OF THE INTRACRANIAL PRESSURE COULD NOT BE COMPLETELY CLAMPED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333252 ↗
• MalfunctionMay 16, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2024, THE CONNECTING TUBE OF THE MEASURING CYLINDER FELL OFF. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333221 ↗
• MalfunctionMay 16, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2024, THE UPPER AND LOWER TUBE CLAMPS OF THE INTRACRANIAL PRESSURE COULD NOT BE COMPLETELY CLAMPED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333182 ↗
• InjuryMay 9, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ANOTHER DEVICE WAS USED. THE PATIENT'S STATUS WAS INTUBATED/CRITICAL AND TRANSFERRED TO ANOTHER HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277026 ↗
• MalfunctionApr 22, 2024Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED IT APPEARED THAT THE FAILURE OCCURRED IN THE SAME AREA THAT ANOTHER MEDTRONIC EXTERNAL DRAINAGE AND MONITORING SYSTEM HAD ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152806 ↗
• MalfunctionApr 22, 2024Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT CEREBROSPINAL FLUID (CSF) LEAKED FROM THE CONNECTION POINT JUST UNDER THE BURETROL. THERE HAD BEEN NO REPORTED DAMAGE TO THE AREA, JUST SPONTANEOUS LEAKING AT THAT SITE TO THE POINT WHERE THE SYSTEM HAD TO BE CHANGED. NO OBVIOUS CRACK WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152794 ↗
• MalfunctionApr 8, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Device Dislodged or Dislocated; Fluid/Blood Leak; Loose or Intermittent Connection; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING NORMAL USAGE AND ROUTINE NURSE CHECKS ON THE PATIENT, IT WAS REALIZED THAT THE TUBING CONNECTING TO THE CHAMBER WAS LOOSE, AND CEREBROSPINAL FLUID (CSF) WAS LEAKING OUT FROM THE FAULTY AREA. THE DEVICE WAS REPLACED WITH A NEW 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 19058718 ↗
• MalfunctionApr 1, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DRAIN WAS USED ACCORDING TO THE STANDARD PROTOCOL. THE DRAIN WAS IN USE FOR 6 DAYS WHEN THE STAFF NOTICED A DISCONNECTION FROM THE DRAIN CHAMBER WHILE ROUNDING ON THE PATIENT. THE DRAIN WAS REMOVED AND 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 19012226 ↗
• InjuryMar 11, 2024Disconnection; Infusion or Flow Problem; Disconnection; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE SYSTEM. IT WAS REPORTED THAT THE SYSTEM WAS SEEN TO HAVE 20ML OF CEREBROSPINAL FLUID (CSF) IN THE COLLECTION CHAMBER. THE SITE CAME BACK TO THE ROOM TO DRAIN IT INTO THE BAG BUT THE CLAMP FAILED AND DRAINED THE ENTIRE 20ML. NEUROSURGERY WAS CALLED TO COME TO THE BEDSIDE AS THE DRAIN DID NOT CLAMP POTENTIALLY CAUSING INACCURATE NUMBERS OF CSF DRAINED. NEUROSURGERY CAME TO BEDSIDE AND REPLACED THE ENTIRE SYSTEM. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874794 ↗
• MalfunctionMar 5, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SYSTEM WAS OPENED ON F EBRUARY 28, 2024 TO PERFORM DEMONSTRATIONS ON USE OF THE DEVICE AT THE HOSPITAL'S CRITICAL CARE UNIT. ON DAY TWO OF PERFORMING THE DEMONSTRATIONS, AS THE CLAMP AT THE BOTTOM OF THE CHAMBER TO DEMONSTRATE DRAINING FLUID WAS SLID, THE TUBE TORE OFF THE TUBE COMING OUT OF THE END OF THE COLLECTION CHAMBER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836449 ↗
• MalfunctionMar 5, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DRAIN WAS LEAKING CSF ONTO THE FLOW FROM A BREAK IN THE TUBING JUST BELOW THE GRADUATED CYLINDER COLLECTION. IT APPEARED THE TUBING PULLED AWAY FROM THE INSERTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836000 ↗
• MalfunctionMar 4, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBE UNDER THE FUNNEL OF THE PRODUCT WAS BROKEN. THE PRODUCT WAS REPLACED, AND TREATMENT CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827557 ↗
• MalfunctionMar 4, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBE UNDER THE FUNNEL OF THE PRODUCT WAS BROKEN. THE PRODUCT WAS REPLACED, AND TREATMENT CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826848 ↗
• MalfunctionMar 4, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBE UNDER THE FUNNEL OF THE PRODUCT WAS BROKEN. THE PRODUCT WAS REPLACED, AND TREATMENT CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826343 ↗
• MalfunctionMar 4, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBE UNDER THE FUNNEL OF THE PRODUCT WAS BROKEN. THE PRODUCT WAS REPLACED, AND TREATMENT CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826171 ↗
• MalfunctionMar 4, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBE UNDER THE FUNNEL OF THE PRODUCT WAS BROKEN. THE PRODUCT WAS REPLACED, AND TREATMENT CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825844 ↗
• MalfunctionMar 4, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBE UNDER THE FUNNEL OF THE PRODUCT WAS BROKEN. THE PRODUCT WAS REPLACED, AND TREATMENT CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825798 ↗