Sophysa SPVBRecalls & reported problems
Sophysa · POLARIS SPV ADJUSTABLE VALVE/BURR HOLE RES. · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03760124131321), received between Nov 29, 2016 and Oct 18, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (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
- Adverse Event Without Identified Device or Use Problem1
- Obstruction of Flow1
Patient problems
- Hydrocephalus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2024Obstruction of Flow; Obstruction of Flow
THE PATIENT HAS BEEN IMPLANTED WITH THE POLARIS VALVE. DUE TO SUSPECTED SHAFT DYSFUNCTION, IT WAS REPLACED FROM SPVB TO SPVA VALVE ON (B)(6) 2024. THE VENTRICULAR CATHETER WAS ALSO REPLACED. THE REASON IS THE DIFFICULTY IN CHANGING THE PRESSURE OF THE VALVE BEFORE THE SURGERY AND THE VISIBLE DEPOSITS INSIDE THE REMOVED VALVE.
Patient problems: Hydrocephalus
MAUDE report 20479074 ↗MalfunctionNov 29, 2016Adverse Event Without Identified Device or Use Problem
A (B)(6) PATIENT PRESENTED SHUNT FAILURE SYMPTOMS. THE VALVE WAS ADJUSTED ON HIGH PRESSURE AND THE FLOW WAS EXCELLENT. THE SYMPTOMS IMPROVED BUT RECURRED. THE USER BELIEVES THAT VALVE TURNED DOWN FROM THE ORIGINAL SETTING TO A LOWER SETTING. THE VALVE WAS ADJUSTED ON HIGH PRESSURE AND THE PROXIMAL FLOW WAS GOOD BUT AN X-RAY EXAMINATION CONFIRMED THAT THE VALVE WAS SET AT A LOWER POSITION. PATIENT WAS TAKEN TO THE OPERATING ROOM. THE VALVE WAS DISCONNECTED FROM THE CATHETERS AND IT SHOWED A GOOD PROXIMAL AND DISTAL FLOW.
Patient problems: Hydrocephalus
MAUDE report 6131919 ↗
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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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