Becker® 26040Recalls & reported problems
Medtronic Ps Medical, Inc. · KIT 26040 BECKER EDMS II · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Medtronic Becker EDMS II kit is used to drain and monitor fluid pressure around the brain. Most of the 46 reports describe the tubing, stopcocks, drip chamber or reservoir cracking, breaking or leaking during neurosurgery, sometimes delaying the procedure; there are no deaths and 1 injury. One open recall, started in November 2024, covers cracks and leaks in the stopcocks of the external drainage system.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00763000333447), received between Mar 22, 2021 and Aug 6, 2025 — classified as 1 injury, 45 malfunctions.
The most frequently reported specific device problem is “Break” (29 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Break29
- Fracture27
- Fluid/Blood Leak19
- Infusion or Flow Problem2
- Adverse Event Without Identified Device or Use Problem1
- Complete Blockage1
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE, WHEN USED, PRODUCED A DEFECT OF FILTRATION. THE DOCTOR INDICATED THE DEVICE WAS CHANGED AND SKEWED FOR BIOSECURITY MEASURES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22725495 ↗MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS A LEAK IN THE UPPER EXTERNAL PART. THE PROCEDURE WAS COMPLETED WITH BACK UP 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 21730555 ↗MalfunctionMar 27, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE PRESENTED WITH FAILURES/DAMAGE IN THE HOSE DUCT OF THE DEVICE. THIS CAUSED A DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACK UP 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 21708277 ↗MalfunctionMar 17, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SPECIALIST DOCTOR INDICATED THAT THE DEVICE PRESENTED A BREAK WHERE THE BURETTE AND HOSE CONNECTION JOINED. THE PROCEDURE WAS COMPLETED WITH BACK UP 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 21619702 ↗MalfunctionMar 7, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DOCTOR FOUND THAT THE DEVICE WAS BROKEN AT THE BURETTE AND THE HOST DUCT AT THE TIME OF THE MEDICAL DEVICE MANIPULATION PROCESS AND COMPLICATED THE PROCESS OF NEUROSURGERY THAT WAS BEING PERFORMED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BACK UP 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 21546322 ↗MalfunctionFeb 25, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE PRESENT FLAWS/FAILURE/DAMAGE IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACK UP 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 21458321 ↗MalfunctionFeb 25, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE PRESENTED A FAI LURE/DAMAGE IN THE RESERVOIR. THE PROCEDURE WAS COMPLETED WITH BACK UP 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 21457973 ↗MalfunctionFeb 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DOCTOR INDICATED THAT THEY PERFORMED THE OPERATION ON THE PATIENT, AND DURING THE PROCESS, THERE WAS A FAILURE OF THE CANNULA OF THE MEDICAL DEVICE PRESENTING EFFUSION. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21333351 ↗MalfunctionJan 30, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS A BROKEN CATHETER ON THE DRAINAGE EQUIPMENT AT THE POINT NEAR THE COLLECTION BAG. THE PROCEDURE WAS COMPLETE WITH BACK UP 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 21272705 ↗MalfunctionJan 27, 2025Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT A DISCONNECTION OCCURRED UNDER THE MILLIMETER TUBE THAT JOINED THE HOSE, AND IT WAS IMPOSSIBLE TO MANIPULATE IT FOR ITS PURPOSE OF USE. THE PROCEDURE WAS COMPLETED WITH BACK UP 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 21241063 ↗MalfunctionJan 21, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS AN INCIDENT THAT WAS IMPOSSIBLE TO MANIPULATE IT FOR ITS PURPOSE OF USE AS THE SYSTEM WAS DAMAGED NEAR THE CLAMPS. THE PROCEDURE WAS COMPLETED WITH BACK UP 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 21196989 ↗MalfunctionJan 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DISTAL CATHETER WAS CHANGED DUE TO CEREBROSPINAL FLUID (CSF) LEAKAGE. THERE WAS A DELAY IN THE SURGICAL 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 21159041 ↗MalfunctionJan 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
(B)(6) 2025 MPXR (B)(6) (FOR, HCP, DIST): MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE EXTERNAL DRAINAGE HAD CEREBROSPINAL FLUID (CSF) LEAK IN THE DRAINAGE CATHETER TO THE COLLECTION BAG WHERE THE CLOSURE CLIP WAS. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THERE WAS A DELAY IN THE SURGICAL 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 21158998 ↗MalfunctionNov 7, 2024Break; Complete Blockage; Fracture; Break; Complete Blockage; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL NOTICED A CRACK IN THE EXTERNAL VENTRICULAR DRAIN (EVD) CATHETER. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20630089 ↗MalfunctionSep 17, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS AN INCIDENT WHERE THERE WAS A CRACK IN THE GRADUATED CHAMBER. THE PROCEDURE WAS COMPLETED WITH BACK UP 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 20238047 ↗MalfunctionSep 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS AN INCIDENT WHERE THERE WAS LEAKAGE IN THE CONNECTION TO THE VENTRICULAR CATHETER. THE PROCEDURE WAS COMPLETED WITH BACK UP 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 20238033 ↗MalfunctionSep 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS AN INCIDENT WHERE THE SYSTEM LEAKED NEAR THE 3-WAY KEY. THE PROCEDURE WAS COMPLETED WITH BACK UP 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 20237978 ↗MalfunctionSep 3, 2024Infusion or Flow Problem; Infusion or Flow Problem
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DEVICE WAS LEAKING AT THE CLAMPS AS THE CLAMP/CLIP OF THE DEVICE TUBE FROM THE CHAMBER TO THE BAG COULD NOT BE LOCKED/TIGHTENED. THE DEVICE WAS MANUALLY TIGHTENED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-WITH INJURY WITH HYDROCEPHALUS. IT WAS CLARIFIED THAT THE PATIENT WAS STILL UNDER HYDROCEPHALUS AFTER USING THE DEVICE, BUT IT WAS NOT DUE TO THE DEVICE. HOWEVER, THE FAULT OF THE DEVICE AFFECT THE CEREBROSPINAL FLUID MANAGEMENT AND LENGTHENED THE TREATMENT TIME. AFTER THE DOCTOR MANUALLY FIXED THE ISSUE, THE PATIENT WAS WELL NOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20125290 ↗MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS REPLACED WITH A NEW ONE. THE PATIENT'S CURRENT STATUS WAS THAT THEY WERE ON A MECHANICAL VENTILATOR DUE TO THEIR MEDICAL ISSUES AND NOT BECAUSE OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19664396 ↗MalfunctionApr 5, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SLIDING CLAMP WHEN CLOSED CUT THE CATHETER. 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 19050608 ↗MalfunctionApr 5, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SLIDING CLAMP WHEN CLOSED CUT THE CATHETER. 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 19050557 ↗MalfunctionMar 27, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SLIDING CLAMP WHEN CLOSED CUT THE CATHETER. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18989520 ↗MalfunctionMar 27, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SLIDING CLAMP WHEN CLOSED CUT THE CATHETER. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18989292 ↗MalfunctionMar 18, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SLIDING CLAMP THAT WHEN CLOSED CUT THE CATHETER. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18923140 ↗MalfunctionMar 7, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SLIDING CLAMP CUT THE CATHETER WHEN CLOSING IT. THE SYSTEM WAS REPLACED 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 18856585 ↗
Other Device, monitoring, intracranial pressure devices
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- CereLink™ 826850Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall2 deaths112 reports
- Duet® 46913Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall58 reports
- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 46129Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall29 reports
- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.