N/A 46420 (UDI 00613994806611)Recalls & reported problems
Medtronic Ps Medical, Inc. · CATH 46420 EDM LUMBAR 80CM/OPEN TIP · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994806611), received between Jul 31, 2020 and Jul 31, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2020Fracture; Fracture
IT WAS REPORTED THAT THE ANESTHESIOLOGIST INSERTED THE LUMBAR CATHETER SUCCESSFULLY, BUT WHEN REMOVING THE NEEDLE, THE CATHETER BROKE 2 CM FROM THE SKIN. THE ANESTHESIOLOGIST SPECIFIED THAT THEY WERE VERY CAREFUL WITH THEIR TECHNIQUE TO AVOID DAMAGE TO THE CATHETER WITH INSERTING THE NEEDLE. IT WAS NOTED THEY COULD NOT REINSERT A NEW CATHETER. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10350708 ↗
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- 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
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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