NA 41207Recalls & reported problems
Medtronic Ps Medical, Inc. · CATH 41207 CSF-VENT SMALL BAR IMP · Class 2 · Implant
Data updated Oct 16, 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 00643169472716), received between May 5, 2017 and May 5, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
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.
MalfunctionMay 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT UPON OPENING THE STERILE BOX, THE DOCTOR REALIZED THAT THE CATHETER WAS LONGER THAN USUAL, AND IT ENDED AT THE MIDDLE OF THE RING OF THE STYLET. ACCORDING TO THE REPORT, THE DOCTOR WASHED THE SURFACE AND TRIED TO REMOVE THE STYLET, BUT THE ACTION WAS DIFFICULT TO PERFORM. REPORTEDLY, THE CATHETER WAS NEVER IMPLANTED AND WAS REPLACED WITH ANOTHER CATHETER. THERE WAS NO PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6549356 ↗
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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
- proSA® FV701TChristoph Miethke GmbH & Co. KG · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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