Sophysa SPVA-SXRecalls & reported problems
Sophysa · POLARIS ADJUSTABLE VALVE, 30-200 WITH ANTECHAMBER AND SIPHONX · Class 2 · Implant
Data updated Oct 13, 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 03760124131710), received between May 25, 2026 and May 25, 2026 — classified as 1 malfunction.
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
- Obstruction of Flow1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2026Obstruction of Flow
A PATIENT WHO HAD A SHUNT VALVE IMPLANTED AT (B)(6) HOSPITAL ON (B)(6) 2023 WAS LATER TRANSFERRED TO (B)(6) HOSPITAL. DURING PUMPING, THERE WAS DISCOMFORT WITH THE VALVE. SUSPECTING A BLOCKAGE, THE VALVE WAS REPLACED WITH A PRODUCT FROM ANOTHER MANUFACTURER.
Patient problems: Discomfort
MAUDE report 25267745 ↗
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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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