Sophysa SPVARecalls & reported problems
Sophysa · POLARIS SPV ADJUSTABLE VALVE/ANTICHAMBER · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03760124131307), received between Sep 12, 2016 and Feb 6, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (4 reports).
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
- Device Difficult to Program or Calibrate4
Patient problems
- Hydrocephalus4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Device Difficult to Program or Calibrate
20 DAYS AFTER INTERVENTION, THE PATIENT RETURNED TO THE HOSPITAL WITH HYDROCEPHALUS SYMPTOMS. THE SURGEON CONTROLED THE PRESSURE TWICE AND HE REALISED THAT THERE WAS A VARIATION OF PRESSURE GOING FROM 110 MMH20 TO 150MMH20. HE EXPLANTED THE VALVE AND IMPLANTED ANOTHER ONE FORM MEDTRONIC.
Patient problems: Hydrocephalus
MAUDE report 24277122 ↗MalfunctionMar 12, 2021Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE SURGEON ADJUSTED THE VALVE TO ITS FOURTH OPERATING PRESSURE, THEN LATER TO ITS FIFTH OPERATING PRESSURE. HOWEVER, UPON PERFORMING AN X-RAY EXAMINATION TO CONFIRM THE ADJUSTMENT, IT WAS FOUND THAT THE VALVE WAS STILL ADJUSTED ON ITS INITIAL OPERATING PRESSURE.
Patient problems: Hydrocephalus
MAUDE report 11472006 ↗MalfunctionDec 1, 2016Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE DEVICE COULD NOT BE ADJUSTED IN ITS STERILE PACKAGING.
Patient problems: Hydrocephalus
MAUDE report 6137804 ↗MalfunctionSep 12, 2016Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE ADJUSTABLE VALVE COULD NOT BE ADJUSTED IN ITS STERILE PACKAGING. IT HAS NOT BEEN IMPLANTED, AND WAS RETURNED TO THE MANUFACTURER IN ITS ORIGINAL PACKAGING.
Patient problems: Hydrocephalus
MAUDE report 5942479 ↗
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- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.