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Sophysa SX-200Recalls & reported problems

Sophysa · SIPHONX GRAVITATIONAL ANTI-SIPHON DEVICE · Class 2 · Implant

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 03760124131697), received between Aug 26, 2016 and Aug 26, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Partial Blockage” (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.

Most reported problems

Device problems

  • Partial Blockage1

Patient problems

  • Hydrocephalus1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 26, 2016Partial Blockage; Partial Blockage

    A PATIENT (SEX AND AGE ARE UNKNOWN) WAS IMPLANTED WITH A POLARIS VALVE AND AN ANTI-SIPHON DEVICE SIPHONX ON (B)(6) 2016. THE PATIENT DEVELOPED HC SYMPTOMS (HEADACHE, VOMITING) AND ENLARGED VENTRICLES. ON (B)(6) 2016 A SHUNT REVISION IDENTIFIED THE MALFUNCTION AS DUE TO THE SIPHONX..

    Patient problems: Hydrocephalus

    MAUDE report 5905984 ↗

Other Shunt, central nervous system and components devices

All Shunt, central nervous system and components devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.