SOPHYSA PSO-PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03760124130782), received between Jan 24, 2017 and May 22, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (4 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Incorrect Measurement

  THE CATHETER WORKED DIRECTLY AFTER THE IMPLANTATION IN OR BUT AFTER A SHORT WHILE SHOWED WRONG NUMBERS (LOW AND HIGH) AND SURGEON CHOOSED TO EXCHANGE IT FOR A NEW ONE WHICH THEN WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252453 ↗
• MalfunctionMay 19, 2026Signal Artifact/Noise

  THE CATHETER WORKED FOR A FEW DAYS THEN STOPPED WORKING (POSSIBLY NOISE SIGNALS, HIGH AND LOW VALUES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215028 ↗
• MalfunctionOct 31, 2025Unexpected Shutdown; Unexpected Shutdown

  AN INTRACRANIAL PRESSURE SENSOR (REFERENCE PSO-PT / SERIAL NUMBER: (B)(6) WAS IMPLANTED ON (B)(6) 2025. WHEN THIS SENSOR IS CONNECTED TO THE MODULE, THE LATTER MALFUNCTIONS: IT TURNS OFF AND ON AGAIN EVEN THOUGH THE BATTERY IS FULLY CHARGED AND THE MODULE IS CONNECTED TO THE MAINS. THIS PREVENTS THE SENSOR FROM BEING CALIBRATED, RENDERING IT UNUSABLE. ANOTHER MONITOR (PSO-4000) IS THEN USED: FAILURE OF THE MONITOR, WHICH GOES INTO DEFAULT MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435525 ↗
• MalfunctionSep 12, 2025Incorrect Measurement; Incorrect Measurement

  THE CATHETER WAS IMPLANTED WITH A GOOD WAVEFORM BUT A NEGATIVE READING FOR ICP OF -8. CATHETER WAS REPLACED AND HAS A GOOD WAVEFORM AND POSITIVE ICP READINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23035524 ↗
• MalfunctionAug 22, 2025Incorrect Measurement; Incorrect Measurement

  ICP CATHETER INSERTED ON (B)(6) 2025, WITH INACCURATE READINGS {NEGATIVE READINGS} AND POOR WAVEFORMS FOR 24 HOURS SO IT WAS REPLACED ON (B)(6) 2025 AND READINGS AND WAVEFORM MUCH BETTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870948 ↗
• MalfunctionAug 20, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  WHEN MONITORING THE PRESSURE, AN ERROR MESSAGE INDICATING AN "INTERNAL MEMORY PROBLEM" APPEARED ON THE MONITOR. CHANGING THE MONITOR DID NOT RESOLVE THE ISSUE. REPLACING THE PRESSURE SENSOR WITH THE SAME REFERENCE RESTORED NORMAL OPERATION. ESTIMATED TIME LOST: APPROXIMATELY 15 MINUTES. THE INCIDENT HAD NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850368 ↗
• MalfunctionJul 21, 2025Unexpected Shutdown; Unexpected Shutdown

  DURING THE SURGERY ON (B)(6) 2025, THE NEUROSURGEON CONNECTED THIS CONSUMABLE TO THE EQUIPMENT, WHICH CAUSED THE MAIN UNIT TO GO BLACK. THE SAME MALFUNCTION OCCURRED REPEATEDLY, WHICH AFFECTED THE SURGICAL PROCESS AND POSED A SIGNIFICANT RISK. AFTER REPLACING WITH THE SAME MODEL PROBE, IT FUNCTIONED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552973 ↗
• MalfunctionMay 28, 2025Device Sensing Problem; Device Sensing Problem

  CATHETER HAD BEEN IMPLANTED IN PATIENT FOR APPROXIMATELY 10 HOURS AND THEN ERRORS E001 AND THEN E002. MONITOR AND MONITOR CABLE CHANGED FOR ANOTHER SET. AND ERROR E002 REMAINED. CATHETER WAS REPLACED WITH A NEW ONE AND WORKED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094862 ↗
• MalfunctionMay 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ICU IN CORK REPORTED A HIGH ICP VALUE. OUR AFTER-SALES MANAGER CONTACTED THE DISTRIBUTOR AND REQUESTED THAT A SERIES OF CHECKS BE PERFORMED. THE DISTRIBUTOR INFORMED US THAT THE PATIENT WAS CONSCIOUS AT THE TIME THE DISTRIBUTOR REPLACED THE MONITOR, BUT THIS HAD NO EFFECT ON THE ICP READING. THEY ALSO REPLACED THE CABLES, BUT THE DISPLAYED ICP REMAINED UNCHANGED. THEY VERIFIED WHETHER THE CATHETER WAS PULLED OR UNDER TENSION; NO TENSION WAS OBSERVED.AT THIS STAGE, IT IS DIFFICULT TO DETERMINE THE CAUSE OF THE ELEVATED ICP VALUE. WE ARE CURRENTLY AWAITING ADDITIONAL INFORMATION TO BETTER UNDERSTAND THE SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059721 ↗
• MalfunctionFeb 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2024, A CATHETER, REFERENCE PSO-PT AND LOT NUMBER 23C42411 WAS IMPLANTED IN A CONTEXT OF INTRACRANIAL HYPERTENSION. ON (B)(6) 2024, THE DEVICE HAS BEEN REMOVED. WHEN THE PRACTITIONER CHECKS THE INTEGRITY OF THE EXPLANTED DEVICE, HE FINDS THAT THE SENSOR (DISTAL METAL TIPTIP OF THE PRESSIO CATHETER) WAS MISSING FROM THE END OF THE FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21331003 ↗
• MalfunctionJan 31, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2024, THE PRACTITIONER PERFORMED AN EXTERNAL DERIVATION OF CEREBROSPINAL FLUID VENTRICULAR OR SUBDURAL FLUID BY TRANSCRANIAL APPROACH/ROUTE. IN DOING SO, HE PERFORMS A SUBCUTANEOUS TUNNELING WITH THE EXTERNAL CSF DRAINAGE SYSTEM EDS 3¿ CODMAN® CSF EXTERNAL DRAINAGE SYSTEM WITH VENTRICULAR CATHETER (INTEGRA LIFESCIENCES) PART NO. (B)(6) AND BATCH NO. (B)(6) AND ATTACH IT TO THE SKIN AT VARIOUS TO THE SKIN. ON (B)(6) 2024, AN INTRACRANIAL PARENCHYMAL SENSOR, REFERENCE PSO-PT LOT NUMBER (B)(6) IS IMPLANTED. DURING A SURGERY, IT WAS REPLACED BY THE SAME DEVICE SAME DEVICE, REFERENCE (B)(4) AND LOT NUMBER (B)(6). ON (B)(6) 2025, WHEN THE SENSOR (PSO-PT AND LOT NUMBER (B)(6)) WAS REMOVED, THE PRACTITIONER NOTICED A SENSATION OF RESISTANCE. WHEN HE CHECKED THE INTEGRITY OF THE EXPLANTED DEVICE, HE NOTICED THAT THE SENSOR (DISTAL METAL TIP OF THE PRESSIO CATHETER) IS MISSING FROM THE END OF THE FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282000 ↗
• MalfunctionJan 24, 2025Device Sensing Problem; Device Sensing Problem

  ERROR E001 OBSERVED ON THE MONITOR. THEN, THE CATHETER HAS BEEN EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228876 ↗
• MalfunctionDec 10, 2024Incorrect Measurement; Incorrect Measurement

  DISTURBANCES ON THE ICP CURVE ON THE PRESSIO MONITOR WHEN ON POWER, BUT OK WHEN RUNNING ON BATTERIES. ICP VALUE "JUMPS" BETWEEN 0 TO 70 MMHG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892171 ↗
• MalfunctionSep 20, 2024Signal Artifact/Noise; Signal Artifact/Noise

  ON (B)(6), AN INTERFERENCE PROBLEM OCCURS ON AN ICP CURVE THAT ALSO DISRUPTED THE ICP MEASUREMENT ON THE PATIENT MONITOR. THE HOSPITAL HAD ESTABLISHED THAT THE MONITOR WORKED PROPERLY ON BATTERY. THE DEPARTMENT MOBILIZED 2 MONITORS TO MONITOR THE PATIENT: 1 CHARGING MONITOR + 1 BATTERY-OPERATED MONITOR . FINALLY THE PATIENT RETURNED TO THE OPERATING ROOM FOR THE REPLACEMENT OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266829 ↗
• MalfunctionJul 30, 2024Device Sensing Problem; Device Sensing Problem

  E002 ERROR DISPLAYED ON MONITOR DURING CLINICAL FOLLOW-UP (POST-IMPLANTATION) LEADING TO DEVICE EXPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19860477 ↗
• MalfunctionSep 26, 2023Electrical /Electronic Property Problem; Device Sensing Problem; Electrical /Electronic Property Problem; Device Sensing Problem

  AFTER APPROX 24 HOURS AN ERROR CODE E001 CAME UP ON THE MONITOR. THE HOSPITAL STAFF TRIED CHANGING THE CONSOLE AND CABLES ALL TO NO EFFECT. THE CATHETER WAS REMOVED AND A NEW ONE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817607 ↗
• MalfunctionMay 29, 2023Output Problem; Output Problem

  IMPLANTATION OF THE DEVICE THE (B)(6). THE MACHINE SHOWED THE INCORRECT PRESSURE AFTER THE PATIENT DID A CT SCAN AT FEBRUARY 10.THE CHIEF PHYSICIAN PUT THE CATHETER INTO THE NORMAL SALINE, THE MACHINE SHOWED 58MMHG.WE DID THE TEST AND THE MACHINE SHOWED 55MMHG. EXPLANTATION OF THE DEVICE THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016916 ↗
• MalfunctionJan 24, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PROBLEM WITH ICP MONITORING KIT: THE CATHETER SHOWED E001 ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6272527 ↗
• MalfunctionJan 24, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PROBLEM WITH ICP MONITORING KIT: THE CATHETER SHOWED E001 ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6272478 ↗

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