Sophysa SPV-2010Recalls & reported problems
Sophysa · POLARIS SPV KIT PREATTACHED/BO19-10 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760124131277), received between Feb 9, 2026 and Feb 9, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2026Patient Device Interaction Problem
A 5-MONTH OLD BABY HAD AN INFECTION FOLLOWING THE SURGERY AND THE DECISION TO EXPLANT A POLARIS VALVE HAS BEEN TAKEN BY THE NEUROSURGEON, A TEMPORARY EXTERNAL DERIVATION WAS PLACED WHILE AWAITING FOR THE IMPLANTATION OF A NEW SOPHYSA VALVE : POLARIS 24 (SPV24). THIS IMPLANTATION WAS PERFORMED DURING CLINICAL INVESTIGATION AND THE SPV24 VALVE IS NOT YET MARKETED BY SOPHYSA. THE INFECTION WAS TRACED TO SURGERY PROCEDURE, THE SHUNT HAS BEEN REMOVED BY PRECAUTION. ALL THESE INFORMATION HAVE BEEN CONFIRMED BY THE HOSPITAL AND THE INCIDENT WAS CONSIDERED AS PREDICTIBLE.
Patient problems: Insufficient Information
MAUDE report 24290899 ↗
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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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