SOPHYSA PSO-PBRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03760124130768), received between Jan 25, 2017 and Nov 5, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K062584); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Unexpected Shutdown; Unexpected Shutdown

  ICP CATHETER REPLACEMENT FOLLOWING ACCIDENTAL SECTIONING. AFTER INSERTION OF THE NEW CATHETER, IT WAS CONNECTED TO THE MONITOR. THE MONITOR BEGAN TO REBOOT. THE MONITOR AND CABLES WERE REPLACED SEVERAL TIMES, WITHOUT SUCCESS. ICP CATHETER REPLACEMENT WAS SUCCESSFUL BUT REQUIRED A NEW CRANIAL INCISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476514 ↗
• MalfunctionMay 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  INSTALLATION OF PIC ON 01/05/25. FUNCTIONAL SURVEY. PARTIAL REMOVAL ON (B)(6) 2025 WITH OBSERVATION THAT THE DISTAL END REMAINED IN PLACE/SECTION OF THE OPINION. NO SURGICAL REVISION INDICATED. TRANSFER TO NEUROSURGERY ON (B)(6) 2025. (B)(6) 2025 NEW NEUROSURGEON OPINION: NO SURGICAL RESECTION. SUCCESSIVE FOLLOW-UP SCANS SUGGEST SUSPECT A SUBCUTANEOUS POSITION, OUTSIDE THE CRANIAL CAVITY. THE PATIENT IS GW=15 WITH NO DEFICIT OR ARGUMENT UNDERLYING INFECTION. NO INDICATION FOR SURGICAL REMOVAL, WHICH WOULD REQUIRE A FURTHER ANAESTHESIA, REMOVAL OF THE FLAP AND A HAZARDOUS SEARCH FOR THIS PIECE (UNDER STERILE CONDITIONS) FOR NO CLINICAL BENEFIT. SHOULD THE CLINICAL SITUATION EVOLVE, THIS POSITION COULD BE RE-EVALUATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095007 ↗
• MalfunctionApr 23, 2025Break; Break

  DURING INSTALLATION OF AN ICP SENSOR, THE DRILL BIT OF THE KIT BROKE IN THE SKULL, DURING INSTALLATION WITH THE DRILL, RESULTING IN A 2ND HOLE DRILLED, AND LARGER INCISION AND DIFFICULTIES IN REMOVING THE DEVICE WITH MOBILIZATION OF THE NEUROSURGEONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21888202 ↗
• MalfunctionFeb 7, 2025Incorrect Measurement; Incorrect Measurement

  ON (B)(6) 2025, AN INTRACRANIAL PRESSURE CATHETER WAS IMPLANTED DURING SURGERY FOR ACUTE LEFT SUBDURAL HEMATOMA. INTRACRANIAL PRESSURE VALUES ARE RAPIDLY NEGATIVE, AS EARLY AS THE DAY OF IMPLANTATION. ON (B)(6) 2025, THE CATHETER WAS REMOVED AS UNRELIABLE, AND A SECOND ONE WAS IMPLANTED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21331013 ↗
• InjuryNov 7, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2022, THE PATIENT UNDERWENT SUBDURAL HEMATOMA DRAINAGE + INTRACRANIAL HEMATOMA DRAINAGE + INTRACRANIAL PRESSURE PROBE IMPLANTATION. THE PURPOSE OF INTRACRANIAL PRESSURE PROBE INSERTION WAS TO MONITOR INTRACRANIAL PRESSURE CHANGES AND MONITOR THE CONDITION. ON (B)(6) 2022, THE PATIENT'S CONDITION WAS STABLE, AND THE INTRACRANIAL PRESSURE PROBE WAS REMOVED. THERE WAS NO RESISTANCE FEELING DURING REMOVAL, AND NO METAL PROBE AT THE TAIL END WAS FOUND AFTER REMOVAL. THE METAL PROBE WAS A FOREIGN BODY WITH INTRACRANIAL PRESENCE, AND AN ELECTIVE REMOVAL WAS PLANNED. THE METAL AT THE END OF THE INTRACRANIAL PRESSURE PROBE LOOSENED AND FELL OFF, CAUSING INDWELLING INTRACRANIAL. / GIVE SYMPTOMATIC TREATMENT TEMPORARILY. WHEN THE TITANIUM MESH REPAIR IS SCHEDULED, THE FOREIGN BODY IS EXPLORED AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20627919 ↗
• MalfunctionApr 2, 2024Device Sensing Problem; Device Sensing Problem

  ERROR MESSAGE E001, DEVICE SENSING PROBLEM.

  Patient problems: Unspecified Infection

  MAUDE report 19017632 ↗
• MalfunctionMar 29, 2022Incorrect Measurement; Incorrect Measurement

  THE PHYSICIAN REPORTED A DIFFERENCE BETWEEN ICP VALUES AND DISPLAYED AMPLITUDE ON THE MONITOR; NO HEALTH CONSEQUENCES REPORTED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939429 ↗
• MalfunctionMar 29, 2022Incorrect Measurement; Incorrect Measurement

  THE PHYSICIAN REPORTED A DIFFERENCE BETWEEN ICP VALUES AND DISPLAYED AMPLITUDE ON THE MONITOR; NO HEALTH CONSEQUENCES REPORTED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939426 ↗
• MalfunctionSep 1, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  THE PROBE HAS IMPLANTED ON (B)(6) 2020 AT NIGHT. ON (B)(6) 2020, THE MONITOR SHOWED E001. DURING THE NIGHT, THE PATIENT WAS RESTLESS, HE COULD HAVE PULLED ON THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476824 ↗
• MalfunctionJan 26, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AFTER 36 HOURS OF IMPLANTATION, ERROR CODE 999 APPEARED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6278359 ↗
• MalfunctionJan 25, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  AFTER PASSING THE MRI, NO MORE VALUES (ERROR CODE E001).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6276104 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062584. One submission often covers many models, so check the product and lot details in each record.

• Z-1826-2024 · Apr 9, 2024 · Open, Classified
  The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT
• Z-1825-2024 · Apr 9, 2024 · Open, Classified
  The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for u