Becker® 46129 (UDI 00763000333683)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00763000333683), received between Jul 4, 2020 and Dec 15, 2025 — classified as 3 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (20 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS A LEAK ON THE EXTERNAL BYPASS SYSTEM. THE DEVICE WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801713 ↗
• MalfunctionOct 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE 3 WAY CONNECTOR. THERE WAS A PROCEDURE DELAY OF 5 MINUTES. 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 20383331 ↗
• MalfunctionOct 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE 3 WAY CONNECTOR ON THE BOARD. THERE WAS A PROCEDURE DELAY OF 5 MINUTES. 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 20383326 ↗
• MalfunctionOct 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DRAINAGE TUBE WAS LEAKING. THIS WAS LIKELY DUE TO THE SLIDING CLAMP. THE PLACE WHERE THE NURSES SLIDE THE CLAMP UPON BEING DONE WITH THE DRAINAGE. THERE WAS A PROCEDURE DELAY OF 5 MINUTES. 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 20383110 ↗
• MalfunctionJun 18, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBING BELOW THE DRIP CHAMBER HAD BECOME DISCONNECTED RESULTING IN AN OPEN SYSTEM AND CEREBROSPINAL FLUID LEAKING. THE DRAIN 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 19557173 ↗
• MalfunctionJun 17, 2024Loose or Intermittent Connection; Device Dislodged or Dislocated; Loose or Intermittent Connection; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBING BECAME DISLODGED BETWEEN THE COLLECTION CHAMBER AND COLLECTION BAG. THE DEVICE WAS ORIGINALLY PLACED ON (B)(6) 2024 AND IN USE FOR 6 DAYS. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT WAS ADMITTED FOR ANEURYSM SUBARACHNOID HEMORRHAGE (SAH) WITH SUBSEQUENT ANEURYSM COIL PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547635 ↗
• MalfunctionJun 17, 2024Loose or Intermittent Connection; Device Dislodged or Dislocated; Loose or Intermittent Connection; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBING BECAME DISLODGED BETWEEN THE COLLECTION CHAMBER AND BAG. THE DEVICE WAS ORIGINALLY PLACED ON (B)(6) 2024 AND WAS IN USE FOR 7 DAYS. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE PATIENT WAS STABLE, AND DRAIN USE WAS DISCONTINUED ON (B)(6) 2024. THE PATIENT WAS ADMITTED FOR CEREBELLA'S MASS RESECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547577 ↗
• MalfunctionApr 10, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS THAT THE CLAMP DID NOT CLOSE SECURELY ON THE TUBING BETWEEN THE COLLECTION CHAMBER AND DRAINAGE BAG, THEREFORE, PREVENTING THE SITE FROM ACCURATELY DETERMINING CEREBROSPINAL FLUID (CSF) DRAINED. THE DEVICE WAS PLACED ON (B)(6) 2024 AND IN PLACE FOR 6 DAYS PRIOR TO FAILURE. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE PATIENT WAS ADMITTED FOR ANEURYSM AI SAH (SUBARACHNOID HEMORRHAGE) WITH SUBSEQUENT ANEURYSM COIL PLACEMENT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078113 ↗
• MalfunctionApr 8, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE WARD CLEANER NOTICED BLOOD LIKE FLUID ON THE FLOOR. THE NURSE WAS INFORMED, AND IT WAS FOUND THAT THE TUBING CONNECTED TO THE CHAMBER WAS DISCONNECTED. 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 19058869 ↗
• MalfunctionMar 27, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE TUBING SLIPPED OUT FROM THE DRIP CHAMBER. THE DEVICE WAS REPLACED AT THE PATIENT'S BEDSIDE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18989652 ↗
• MalfunctionFeb 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DRAINAGE SYSTEM WAS LEAKING FROM ALL CONNECTIONS DURING THE PLACEMENT OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798138 ↗
• MalfunctionFeb 21, 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 EXTERNAL VENTRICULAR DRAIN (EVD) WAS INSERTED ON (B)(6) 2024, AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU SINCE THE OPERATION. THE STANDARD OPERATING PROCEDURE IN THE ICU WAS TO DRAIN THE CEREBROSPINAL FLUID (CSF) EVERY 4 HOURS. DUE TO THE OPEN/CLOSING OF THE MANUAL CLAMPS TO EMPTY THE CHAMBER, RESULTING IN WEAR AND TEAR OF THE TUBING. THUS RESULTING IN A CRACK IN THE TUBING. THE CRACK AND LEAKAGE OF THE CSF TOOK PLACE ON (B)(6) 2024. A NEW EVD WAS PLACED FOR THE PATIENT UNDER STERILE PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748707 ↗
• MalfunctionFeb 21, 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 EXTERNAL VENTRICULAR DRAIN (EVD) WAS INSERTED ON (B)(6), 2024, AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU SINCE THE OPERATION. THE STANDARD OPERATING PROCEDURE IN THE ICU WAS TO DRAIN THE CEREBROSPINAL FLUID (CSF) EVERY 4 HOURS. DUE TO THE OPEN/CLOSING OF THE MANUAL CLAMPS TO EMPTY THE CHAMBER, RESULTING IN WEAR AND TEAR OF THE TUBING. THUS RESULTING IN A CRACK IN THE TUBING. THE CRACK AND LEAKAGE OF THE CSF TOOK PLACE ON (B)(6) 2024. A NEW EVD WAS PLACED FOR THE PATIENT UNDER STERILE PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748361 ↗
• MalfunctionJan 30, 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 TUBING ON THE SYSTEM AROUND THE WHITE SLIDE CLAMP HAD SPLIT AND WAS LEAKING CEREBROSPINAL FLUID (CSF). THE CUSTOMER HAD TO CLAMP THE TUBING TO PREVENT FURTHER LEAKING OF CSF. THE SYSTEM WAS REPLACED WITH A DIFFERENT SYSTEM, AND THE PATIENT WAS CURRENTLY CONNECTED TO THAT DRAINAGE 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 18605853 ↗
• MalfunctionAug 16, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THERE WAS A BROKEN PORT AND THE DEVICE WAS LEAKING. THE DEVICE WAS REPLACED WITH A NEW ONE AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557820 ↗
• MalfunctionMay 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING EXTERNAL DRAINAGE AND MONITORING DEVICES. IT WAS REPORTED THE DEVICE WAS LEAKING FROM THE STOP COCK AREA. THE CUSTOMER WAS NOTED TO BE SEASONED WITH THIS DEVICE AND ALWAYS USES THE BECKER SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946425 ↗
• MalfunctionMay 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING EXTERNAL DRAINAGE AND MONITORING DEVICES. IT WAS REPORTED THE DEVICE WAS LEAKING FROM THE STOP COCK AREA. THE CUSTOMER WAS NOTED TO BE SEASONED WITH THIS DEVICE AND ALWAYS USES THE BECKER SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946252 ↗
• MalfunctionMay 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING EXTERNAL DRAINAGE AND MONITORING DEVICES. IT WAS REPORTED THE DEVICE WAS LEAKING FROM THE STOP COCK AREA. THE CUSTOMER WAS NOTED TO BE SEASONED WITH THIS DEVICE AND ALWAYS USES THE BECKER SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946148 ↗
• MalfunctionMay 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE DEVICE WAS LEAKING FROM THE STOP COCK AREA. THE CUSTOMER WAS NOTED TO BE SEASONED WITH THIS DEVICE AND ALWAYS USES THE BECKER SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945941 ↗
• InjuryFeb 23, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS). IT WAS REPORTED THE CLAMP ON THE EDMS WAS FAILING, CAUSING CSF OUTPUT TO GO DIRECTLY TO THE DRAINAGE BAG INSTEAD OF REMAINING IN THE MEASURING CHAMBER. THERE WAS ALSO A SPONTANEOUS BREAK AND DISCONNECTION IN THE CIRCUIT PROXIMAL FROM THE MEASURING CHAMBER TO DRAINAGE BAG. THE PLASTIC NECK JOINT SEALING THE CIRCUIT WAS FOUND TO BE MISSING. THE POSSIBLE CAUSE WAS A A METAL CLAMP WAS APPLIED TO REINFORCE THE PLASTIC CLIPS THAT WAS FAILING. THE PATIENT ASSESSED BY MEDICAL STAFF RECEIVED NO IMMEDIATE HARM, AND HOURLY NEURO OBS CONTINUES FOR PATIENTS. ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE WAS CLAMPED TO THE PATIENT. THE DEVICE WAS EXAMINED TO DETERMINE IF AIR ENTRAINED TOWARDS THE PATIENT. NIL AIR DETECTED AS TUBING LEADING FROM PATIENT TO DRAIN STILL FILLED WITH CSF. THE DEVICE WAS CHANGED UNDER STERILE CONDITIONS AND THE PATIENT ALSO RECEIVED STAT DOSE OF ANTIBIOTICS. PRIOR TO THE INCIDENT, TWO CLIP CLAMPS WERE NOT HOLDING AND CAUSING THE DRAINAGE OF CSF DIRECTLY INTO THE DRAINAGE BAG INSTEAD OF MEASURING THE CHAMBER. THE EVENT OCCURRED ON (B)(6).

  Patient problems: Coma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16429890 ↗
• InjuryFeb 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. THE PATIENT WAS BEING FITTED TO MONITOR ICP. IT WAS REPORTED THAT THERE WAS LEAK AT THE CONNECTION SITE IN THE DRAIN. THERE WAS NO REPORTED INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326368 ↗
• MalfunctionFeb 28, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTRA VENTRICULAR DRAINAGE (EVD) SYSTEM POST-OPERATIVELY. IT WAS REPORTED THAT THERE WAS A HOLE IN THE TUBING DURING THE UNCLAMPING OF THE DEVICE FOR CSF DRAINAGE PROCESS. THE CHANGED THE EVD. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS DISCOVERED DURING THEIR HOURLY UNCLAMPING OF THE TUBING FOR CSF DRAINAGE. WHEN THE SITE STATES UNCLAMP THEY MEAN SLIDE CLAMP. THE HOLES WERE LOCATED ON THE DRAINAGE BAG COLLECTION LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621253 ↗
• MalfunctionFeb 17, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE EXTRA VENTRICULAR DRAINAGE (EVD) LINE BROKE IN THE WARD. IT WAS REMOVED. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13551766 ↗
• MalfunctionFeb 17, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE SYSTEM. IT WAS REPORTED THAT THE EXTERNAL DRAINAGE HAD A HOLE IN THE EXTRA VENTRICULAR DRAINAGE (EVD) TUBING DURING USE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13551163 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED THAT THE TUBING WAS FOUND WITH A PUNCTURED HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253186 ↗