N/A 46420 (UDI 00763000027278)Recalls & reported problems
Medtronic Ps Medical, Inc. · CATH 46420 EDM LUMBAR 80CM/OPEN TIP · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000027278), received between May 5, 2021 and Nov 10, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Break1
- Disconnection1
Patient problems
- Device Embedded In Tissue or Plaque3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2025Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DUE TO A SUBARACHNOID HEMO RRHAGE, A DRAINAGE TUBE WAS LEFT IN PLACE FOR THE PATIENT. ON (B)(6) 2025, THE PATIENT'S FAMILY ACCIDENTALLY PULLED OUT THE LUMBAR EXTERNAL DRAINAGE TUBE WHILE ASSISTING THE PATIENT TO TURN OVER. THE DRAINAGE TUBE WAS IMMEDIATELY DISINFECTED, RECONNECTED, AND PROPERLY SECURED. THE EVENT CAUSE PER THE HCP WAS THE CONNECTOR OF THE LUMBAR EXTERNAL DRAINAGE DEVICE WAS LOOSE AND EASILY DISLODGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23510013 ↗InjuryJun 26, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A LUMBAR CATHETER. IT WAS REPORTED THAT THE RESIDENT NEUROSURGEON PLACED THE LUMBAR CATHETER, AND WHEN THE TUOHY NEEDLY WAS PULLED BACK THE CATHETER WAS CUT. THE PATIENT UNDERWENT AN OPERATION TO RETRIEVE THE BROKEN PIECE OF THE CATHETER. THE PRODUCT WAS RETRIEVED. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19613325 ↗InjuryJan 26, 2022Fracture; Fracture
IT WAS REPORTED THAT THE CATHETER TIP HAD BROKEN INSIDE THE PATIENT. IT WAS NOTED THE PATIENT WAS IN CRITICAL CARE, AND THE SURGICAL REMOVAL OF THE TIP OF THE CATHETER DEPENDED ON THE CONDITION OF THE PATIENT MOVING FORWARD.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 13361387 ↗MalfunctionMay 25, 2021Fracture; Fracture
IT WAS REPORTED THAT WHILE PLACING THE CATHETER THROUGH THE NEEDLE, THE CATHETER BROKE, LEAVING THE TIP IN THE PATIENT. THE PATIENT'S STATUS WAS OKAY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11879327 ↗MalfunctionMay 5, 2021Fracture; Fracture
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS INDICATED THAT THE ACTIONS TAKEN TO RESOLVE THE ISSUE WERE EMERGENT NEUROSURGERY CONSULT TO EVALUATE PATIENT, X-RAYS TAKEN TO IDENTIFY LOCATION OF THE FRACTURED CATHETER TIP, AND THE SURGERY CANCELLED. IT WAS NOTED THERE WAS A POTENTIAL RISK TO THE PATIENT IF THE RETAINED PIECE WOULD MIGRATE CAUSING FUTURE NEUROLOGIC DEFICIT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11779001 ↗
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- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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