BeckerRecalls & reported problems across all models
Medtronic Ps Medical, Inc. · 28 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Becker model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 259
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 1
We found 28 models of Becker by Medtronic Ps Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 259 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and Apr 20, 2026 — classified as 9 injuries, 250 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (129 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Becker recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 1, 2024Class IOpen, 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 · names 20 of these models · Recall details · FDA record ↗
Most reported Becker problems
Device problems
- Fluid/Blood Leak129
- Break84
- Fracture76
- Disconnection49
- Infusion or Flow Problem15
- Insufficient Device Problem Information12
- Loose or Intermittent Connection7
- Device Dislodged or Dislocated4
Patient problems
- No Clinical Signs, Symptoms or Conditions219
- No Known Impact Or Consequence To Patient40
- No Consequences Or Impact To Patient2
- Coma1
- Unspecified Infection1
- Unspecified Tissue Injury1
Becker models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Becker® 46128Shunt, central nervous system and components1 recall50 reports
- Becker® 26040Device, monitoring, intracranial pressure1 recall46 reports
- Becker® 46129Device, monitoring, intracranial pressure1 recall29 reports
- Becker® 25120Device, monitoring, intracranial pressure1 recall15 reports
- Becker® 27931Device, monitoring, intracranial pressure1 recall14 reports
- Becker® 27779Shunt, central nervous system and components1 recall13 reports
- Becker 27779Device, monitoring, intracranial pressure1 recall12 reports
- Becker 46128Shunt, central nervous system and components1 recall10 reports
- Becker 46129Shunt, central nervous system and components1 recall9 reports
- Becker® 27761Shunt, central nervous system and components1 recall8 reports
- Becker® 27702Device, monitoring, intracranial pressure1 recall3 reports
- Becker® 27609Device, monitoring, intracranial pressure1 recall2 reports
- Becker® 24146Device, monitoring, intracranial pressure1 recall1 report
- Becker® 27670Device, monitoring, intracranial pressure1 recall0 reports
- Becker® 27672Shunt, central nervous system and components1 recall0 reports
- Becker® 27767Shunt, central nervous system and components1 recall0 reports
- Becker® 27811Device, monitoring, intracranial pressure1 recall0 reports
- Becker 25120Device, monitoring, intracranial pressure1 recall0 reports
- Becker 27702Device, monitoring, intracranial pressure1 recall0 reports
- Becker 27609Shunt, central nervous system and components1 recall0 reports
- Becker® 46128DEVICE, MONITORING, INTRACRANIAL PRESSURE32 reports
- Becker® 27702DEVICE, MONITORING, INTRACRANIAL PRESSURE4 reports
- Becker® 46124Shunt, central nervous system and components3 reports
- Becker® 27779DEVICE, MONITORING, INTRACRANIAL PRESSURE3 reports
- Becker® 46129Shunt, central nervous system and components2 reports
- Becker® 27670Shunt, central nervous system and components1 report
- Becker® 27761DEVICE, MONITORING, INTRACRANIAL PRESSURE1 report
- Becker® 46124Device, monitoring, intracranial pressure1 report
Recent Becker adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PRODUCT RUPTURED. NO PATIENT PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931962 ↗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 ↗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 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 ↗MalfunctionSep 8, 2025Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORY SYSTEM. IT WAS REPORTED THAT THE DRAIN TUBING BROKE OFF THE Y PORT ON THE PRESSURE TUBING CONNECTED TO THE DRAIN. THE 3-WAY STOP COCK PROXIMAL TO PATIENT WAS IMMEDIATELY CLOSED TO THE PATIENT, AND THE DRAIN CLAMPED. A NEW DRAIN SET UP WAS OBTAINED AND SET UP, CONNECTED TO PATIENT, DRAIN RELEVELED AND ZEROED WITH GOOD WAVE FORM DISPLAYED ON THE MONITOR, ICP [INTRACRANIAL PRESSURE] 14.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22992485 ↗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 ↗MalfunctionAug 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM BAG. IT WAS REPORTED THAT THE BAG FAILED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903137 ↗MalfunctionAug 25, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT 3 DEVICES IN A ROW FAILED IN THE OPERATING ROOM AS THE CONNECTOR WAS CRACKED. A 4TH DEVICE WAS OPENED AND SUCCESSFULLY USED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882646 ↗MalfunctionAug 25, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT 3 DEVICES IN A ROW FAILED IN THE OPERATING ROOM AS THE CONNECTOR WAS CRACKED. A 4TH DEVICE WAS OPENED AND SUCCESSFULLY USED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882640 ↗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 ↗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 ↗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 ↗
Other Medtronic Ps Medical, Inc. products
All Medtronic Ps Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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