Becker 27779Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000529345), received between May 17, 2024 and Oct 22, 2025 — classified as 12 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.

6 other recalls cover devices cleared under the same FDA submission (K984053); they may or may not involve this specific model.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE EXTERNAL VENTRICULAR DRAIN (EVD) THAT WAS ATTACHED TO THE PATIENT BEGAN LEAKING AT THE DRAIN BAG SITE BELOW THE COLLECTION CHAMBER. CEREBROSPINAL FLUID (CSF) WAS NOTED ON THE FLOOR AND MOISTURE WAS NOTED AT THE CONNECTION SITE. AFTER THE EVD WAS CHANGED, IT WAS NOTED THAT THE CONNECTION WITH THE TUBING WAS NOT SECURE AND THE TUBING WAS DETACHED FROM THE COLLECTION CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357535 ↗
• MalfunctionAug 28, 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 NURSE NOTED FLUID ON THE OUTSIDE OF THE DEVICE. PERFORATION WAS LOCATED IN THE TUBING BELOW THE DRIP CHAMBER AND BEFORE THE DRAINAGE BAG. PERFORATION WAS ON THE TUBING ITSELF AND NOT AT A JOINT LOCATION. THE DEVICE WAS IN USE FOR 8 DAYS. THE DEVICE WAS NOT PRE-TESTED PRIOR TO USE. A SECOND DEVICE WAS REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911206 ↗
• MalfunctionJul 16, 2025Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE HEALTHCARE PROFESSIONAL (HCP) WENT TO CHANGE THE DEVICE'S BAG AS IT WAS 3/4 FULL. WHEN THE HCP WENT TO REMOVE THE BAG FROM LEUR LOCK SYSTEM, THEY WERE UNABLE TO REMOVE THE OLD BAG. THE HCP REQUIRED KELLY CLAMPS TO REMOVE THE OLD BAG FROM THE SYSTEM. WHEN THE HCP WAS USING THE KELLY CLAMPS TO REMOVE THE OLD BAG, THE BAG DISCONNECTED FROM THE LEUR LOCK SYSTEM AND FELL TO GROUND AND DID LEAK MINIMALLY FROM THE TOP OF BAG. HOWEVER, THE LEUR LOCK OF OLD BAG REMAINED IN PLACE EVEN THROUGH THE BAG DISCONNECTION. THE HCP WAS ABLE TO SUCCESSFULLY REMOVE THE BAG AFTER GREAT DIFFICULTY WITH THE KELLY CLAMPS. THE SYSTEM END WAS CLEANED WITH CHLOROHEXIDINE AND THE BAG SPOUT. BOTH WERE ALLOWED TO DRY BEFORE CONNECTING THE NEW DRAINAGE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519025 ↗
• MalfunctionJul 7, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DRIPPING WAS NOTED FROM THE DEVICE. ON OBSERVATION, THERE WAS A CRACK IN THE DEVICE BELOW THE DRIP CHAMBER AND ABOVE THE COLLECTION BAG. THE DEVICE WAS IN USE FOR 8 DAYS. THE DEVICE WAS NOT PRE-TESTED PRIOR TO USE. A SECOND DEVICE WAS REQUIRED. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412845 ↗
• MalfunctionJun 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE WAS INSERTED ON (B)(6) 2025, AND A LEAK WAS IDENTIFIED OVERNIGHT ON (B)(6) 2025 FROM THE TUBING BELOW THE BURITROL CONNECTING TO THE DRAINAGE BAG. THE DRAINAGE SYSTEM WAS CHANGED TO A NEW SYSTEM. HOWEVER, THE NEW SYSTEM WAS LEAKING AT THE CONNECTION POINT BETWEEN THE LUMBAR CATHETER AND DRAINAGE SYSTEM LUER LOCK. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184531 ↗
• MalfunctionJun 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE WAS INSERTED ON (B)(6) 2025, AND A LEAK WAS IDENTIFIED OVERNIGHT ON (B)(6) 2025 FROM THE TUBING BELOW THE BURITROL CONNECTING TO THE DRAINAGE BAG. THE DRAINAGE SYSTEM WAS CHANGED TO A NEW SYSTEM. HOWEVER, THE NEW SYSTEM WAS LEAKING AT THE CONNECTION POINT BETWEEN THE LUMBAR CATHETER AND DRAINAGE SYSTEM LUER LOCK. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184515 ↗
• MalfunctionJan 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS LEAKING CEREBROSPINAL FLUID (CSF)/BLOOD AT THE BASE OF THE COLLECTION CHAMBER AND WITH THE SLIDE CLAMPS CLOSED, THE DEVICE CONTINUED TO LEAK INTO THE BAG. IT WAS NOTED THE PATIENT HAD 2 EXTERNAL VENTRICULAR DRAINAGE SYSTEMS, ONE ON THE RIGHT AND ONE ON THE LEFT. THE EXTERNAL VENTRICULAR DRAIN WITH THE LEAK ALSO HAD DIFFERENT PORTS AND UNKNOWN IF THIS WAS RELATED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078739 ↗
• MalfunctionDec 30, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE CEREBROSPINAL FLUID (CSF) WAS BYPASSING THE TWO PLASTIC CLAMPS LEADING FROM THE DRIP CHAMBER TO THE DRAINAGE BAG RESULTING IN INACCURATE MEASUREMENT OF HOURLY CSF DRAINAGE. THERE WAS NO REPORTED INJURY. THE SITE CONTINUED TO USE THE DEVICE WITH AN ADDITIONAL EXTERNAL CLAMP APPLIED TO THE TUBING UNTIL IT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034396 ↗
• MalfunctionAug 20, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE LINE SEPARATED FROM BELOW THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002058 ↗
• MalfunctionJul 22, 2024Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE FELL APART BELOW THE COLLECTION CHAMBER. THE HEALTHCARE PROFESSIONAL FELT IT WAS THE ADHESIVE HOLDING THE TUBING TOGETHER. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THERE WAS NO HARM TO THE PATIENT, AND THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794080 ↗
• MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DRAIN WAS LEAKING FROM THE BOTTOM OF THE COLLECTION BURETTE WHERE THE TUBE CONNECTED TO IT AND CLAMPED OFF. THE DRAIN WAS REPLACED WITH ANOTHER MANUFACTURER'S DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19664484 ↗
• MalfunctionMay 17, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THIS CASE THE DEVICE WAS BEING UTILIZED AS A LUMBAR DRAIN AS IT CAN BE WITH ITS DUAL PURPOSE USE. CEREBROSPINAL FLUID (CSF) BEGAN LEAKING RANDOMLY BELOW THE COLLECTION CHAMBER. WHEN THE NURSING STAFF NOTICED THE LEAKING, THEY DID TOUCH THE SITE AND THE TUBING FELL OUT WITHOUT ANY KIND OF FORCE. THE DEVICE WAS REPLACED WITH 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 19339984 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K984053. One submission often covers many models, so check the product and lot details in each record.

• Z-2412-2023 · Jun 28, 2023 · Open, Classified
  Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
• Z-1922-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrosp
• Z-1920-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and o
• Z-1923-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrosp
• Z-1924-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal
• Z-1921-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and o