Sophysa SPVRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03760124131253), received between Feb 27, 2025 and Jul 22, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (2 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Insufficient Device Problem Information

  The surgeon suspected a possible valve malfunction. The valve was explanted several days after the surgery.

  Patient problems: Speech Disorder

  MAUDE report 25905696 ↗
• MalfunctionNov 7, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  AN 86-YEAR-OLD PATIENT UNDERWENT VENTRICULOPERITONEAL SHUNTING SURGERY ON (B)(6) 2025, WITH THE PLACEMENT OF A POLARIS 400 VALVE FOR HYDROCEPHALUS. THE POSTOPERATIVE PERIOD WAS UNEVENTFUL, WITH A MARKED IMPROVEMENT IN WALKING AND SPHINCTER DISORDERS. THE PATIENT RETURNED FOR A CONSULTATION DUE TO A RECURRENCE OF WALKING AND SPHINCTER DISORDERS, WITHOUT ASSOCIATED HEADACHE. A BRAIN CT SCAN WAS THEN PERFORMED, REVEALING BILATERAL SUBDURAL HEMATOMAS WITH MASS EFFECT. THE EXAMINATION FOUND THAT THE VALVE WAS SET AT 70 MMH2O, WHEREAS IT HAD INITIALLY BEEN SET AT 200 MMH2O POSTOPERATIVELY. THE PATIENT THEREFORE UNDERWENT FURTHER SURGERY ON (B)(6) 2025, WITH REPLACEMENT OF THE VALVE.

  Patient problems: Movement Disorder

  MAUDE report 23494678 ↗
• MalfunctionJun 17, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  ON (B)(6), REVISION SURGERY WAS PERFORMED ON A PATIENT WITH AN SPV IMPLANT, AND THE SPV WAS PLACED IN THE SAME LOCATION. ON THE FOLLOWING DAY, (B)(6), THE PRESSURE WAS ATTEMPTED TO BE CHANGED, BUT THIS WAS NOT POSSIBLE. DESPITE PROLONGED ATTEMPTS UNDER FLUOROSCOPY, THE MICRO MAGNET DID NOT MOVE, SO SURGERY WAS PERFORMED IN THE AFTERNOON ON (B)(6), AND ANOTHER SPV WAS IMPLANTED. THE DOCTOR REQUESTED A REPLACEMENT. THE MICRO MAGNET FROM THE REMOVED VALVE COULD BE MOVED WITH A MAGNET, SO THERE WAS NO REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22218245 ↗
• MalfunctionFeb 28, 2025Obstruction of Flow; Obstruction of Flow

  AN INCIDENT OCCURED ON A SPV VALVE, THE PRODUCT HAS BEEN FOUND OBSTRUCTED. THE VALVE HAS BEEN EXPLANTED AND REPLACED BY ANOTHER SPV VALVE ON (B)(6) 2024. THE PATIENT IS A 7 YEARS OLD CHILD THAT PRESENTED A HYPERPROTEINEMIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21489350 ↗
• InjuryFeb 27, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE VALVE SPV WAS IMPLANTED IN (B)(6) 2023 AND ADJUSTED AT 150 MMH2O. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO EMERGENCY WITH HEADACHES. THE VALVE WAS ADJUSTED AT 200 MMH2O AND THE DOCTOR READJUSTED THE VALVE TO 150 MMH2O. ON (B)(6) 2025, THE PATIENT RETURNED TO HOSPITAL AS HIS STATE OF HEALTH HAD NOT IMPROVED. THE VALVE WAS EXPLANTED AND REPLACED WITH THE SPV 300 AND ADJUSTED TO 150 MMH2O. FOLLOWING VALVE REPLACEMENT, THE PATIENT'S HEALTH CONDITION IMPROVED.

  Patient problems: Hydrocephalus

  MAUDE report 21478993 ↗