Natus® NT97105S01Recalls & reported problems
Natus Medical Incorporated · Spetzler™ Lumbar Peritoneal Shunt System · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382830057288), received between Oct 4, 2024 and Oct 4, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- Bacterial Infection1
- Meningitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2024Off-Label Use; Off-Label Use
PART NT97105S01 - SPETZLER LUMBAR-PERITONEAL SHUNT KIT, 105CM CATHETER. THE CATHETER WAS IMPLANTED IN THE SUBJECT ON (B)(6) 2023. FOLLOWING INSERTION OF THE CATHETER THERE WAS DELAYED WOUND HEALING OF THE FOREHEAD WOUND. THE CATHETER WAS EXPLANTED ON (B)(6) 2024. THE OFF-LABEL USE OF THE CATHETER IN THIS STUDY (MTX110-102) HAS CAUSED THE DEVICE DEFICIENCY TO BE AN EXPEDITED REPORTABLE SERIOUS ADVERSE DEVICE EFFECT (SADE). RELATED TO MEDWATCH FORM REF. MFR REPORT # 2024-US-000053.
Patient problems: Bacterial Infection; Meningitis
MAUDE report 20367324 ↗
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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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