Sophysa SM8Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03760124131093), received between Sep 8, 2016 and Nov 20, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CHILDREN WAS HAVING A CONTROL MR SCAN AFTER THE PLACEMENT OF A PERITONEAL VENTRICLE SHUNT (FROM THE BRAIN, UNDER THE SKIN TO THE ABDOMINAL REGION). THE PATIENT WAS PLACED ON THE MR TABLE AND POSITIONED. RIGHT AFTER BEING POSITIONED THE PATIENT INFORMED HIS MOTHER (THAT WAS ON THE ROOM WITH HIM) THAT HE FELT MOVEMENT OF THE SHUNT IN THE ABDOMINAL REGION. THE PATIENT WAS REMOVED FROM THE SYSTEM AND EVALUATED BY THE TEAM THAT HAD OPERATED HIM. THE INFORMATION WE HAVE AT THE MOMENT IS THAT NO SERIOUS INJURY HAS OCCURRED, BUT THE PATIENT WILL HAVE TO BE SUBMITTED TO ANOTHER SURGERY TO CORRECT THE PLACEMENT OF THE SHUT IN THE ABDOMINAL REGION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733421 ↗
• InjuryOct 30, 2024Inaccurate Delivery; Inaccurate Delivery

  A PATIENT IN CHINA RECEIVED A SOPHY SM8 VALVE IMPLANT IN (B)(6) 2020 FOLLOWING AN ICH AND OPEN-SKULL SURGERY. TWO WEEKS AFTER THE PROCEDURE, IN EARLY SEPTEMBER, THE PATIENT'S DOCTOR SUSPECTED VALVE OVER DRAINAGE. THE VALVE'S RELEASE PRESSURE WAS INITIALLY SET TO 110 MMH2O AND WAS THEN ADJUSTED TO 140MMH2O. HOWEVER, TWO WEEKS AFTER THIS FIRST ADJUSTMENT, THE DOCTOR OBSERVED THAT THE RELEASE PRESSURE REMAINED TOO LOW AND RE-ADJUSTED IT TO 200MMH2O ON (B)(6) 2024. DESPITE THIS ADJUSTMENT, A PRESSURE MEASUREMENT TEST CONDUCTED BY THE HOSPITAL ON (B)(6) 2024, INDICATED THAT THE ACTUAL PRESSURE WAS ONLY 170MMH2O. THE OVER DRAINAGE IS NOT RESOLVED AND THE LOW PRESSURE HAS POTENTIALLY CAUSED SEVERE NEURAL DAMAGE. CURRENTLY THE VALVE REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: Nerve Damage

  MAUDE report 20566303 ↗
• MalfunctionOct 13, 2016Decrease in Pressure; Pressure Problem; Decrease in Pressure; Pressure Problem

  SUSPISION OF CHRONIC HYPODRAINAGE, DESPITE THE VALVE BEING IN THE LOW POSITION. THE VALVE HAD TO BE EXPLANTED.

  Patient problems: Hydrocephalus

  MAUDE report 6026372 ↗
• MalfunctionSep 8, 2016Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  THE VALVE DOES NOT FUNCTION, THERE IS NO CSF FLOW.

  Patient problems: Hydrocephalus

  MAUDE report 5935468 ↗