Sophysa SPV-400Recalls & reported problems
Sophysa · POLARIS ADJUSTABLE VALVE 400 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03760124131291), received between Sep 28, 2020 and Mar 20, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Excess Flow or Over-Infusion1
- Obstruction of Flow1
Patient problems
- Hydrocephalus2
- Headache1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2024Obstruction of Flow; Obstruction of Flow
THE PATIENT IS SUFFERING FROM HYDROCEPHALUS AND HAS BEEN IMPLANTED BY ADJUSTABLE VALVE WITH VENTRICULOPERITONEAL SHUNT SINCE 2016. ON THE (B)(6) 2024, THE PATIENT UNDERWENT A PROCEDURE TO CHANGE THE SHUNT DUE TO HEADACHES. THERE WAS NO OBSTRUCTION, HOWEVER BOTH OF THE VALVE AND THE INTRACEREBRAL CATHETER WERE REPLACED WITH A POLARIS VALVE AND INTRACEREBRAL CATHETER FROM SOPHYSA. THE FOLLOWING DAY, THERE WAS NO IMPROVEMENT IN THE PATIENT'S HEALTH STATE EVEN AFTER SEVERAL VALVE ADJUSTMENTS. ON THE (B)(6) 2024, THE PATIENT RETURNED TO THE OPERATING ROOM TO REPLACE THE POLARIS VALVE DUE TO THE FACT THAT THE STATE OF HEALTH IS NOT IMPROVING. THE VALVE IS MALFUNCTIONING AND OBSTRUCTED AT THE EXTREMITY OF IT AND THE PERITONEAL CATHETER. THE PHYSICIAN REPLACED THE POLARIS VALVE WITH ANOTHER ADJUSTABLE VALVE. THE PATIENT'S CONDITION HAS IMPROVED.
Patient problems: Hydrocephalus
MAUDE report 18938758 ↗MalfunctionSep 28, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
PATIENT UNDERWENT SURGERY (B)(6) 2020. 1.5 WEEKS POST-OP, SHE DEVELOPED CLEAR LOW PRESSURE HEADACHES. ATTEMPTED ADJUSTMENT TO 400 SEVERAL TIMES. THE PATIENT CONTINUED TO HAVE HEADACHES. UNSUCCESSFUL ADJUSTMENT. VALVE WAS FOUND IN APPRORPIATE POSITION. WHEN EXTERNALISED VALVE WAS NOT ADJUSTING.
Patient problems: Headache; Hydrocephalus
MAUDE report 10592577 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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