Sophysa PSO-PBTRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03760124131758), received between Nov 16, 2020 and Nov 10, 2025 — classified as 1 death, 19 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (11 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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Unexpected Shutdown; Unexpected Shutdown

  AFTER PERFORMING THE ZEROING PROCEDURE ON THE PIC CATHETER SENSOR, THE MONITOR AUTOMATICALLY SHUT DOWN AND RESTARTED WHEN THE MEASUREMENT OF ICP AND ICT VALUES WAS INITIATED. THE MONITOR OR THE CONNECTING CABLE, BOTH COMPONENTS WERE REPLACED AND THE SENSOR WAS TESTED ON DIFFERENT'S MONITORS. HOWEVER, IN ALL CASES, AFTER SEVERAL SECONDS OF MEASUREMENT, THE MONITOR REPEATEDLY RESTARTED. THE CATHETER REPLACEMENT HAS CORRECTED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510336 ↗
• MalfunctionSep 17, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CATHETER WAS PLACED AS USUAL WITH NO IMMEDIATE ISSUES. AFTER DISCONNECTING THE CATHETER FROM THE EXTENSION CABLE AND ATTEMPTING TO RECONNECT IT, THE PRESSIO BEGAN CYCLING ON AND OFF REPEATEDLY, RENDERING IT UNUSABLE. CONNECTING A SPARE NEW CATHETER RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071773 ↗
• MalfunctionJun 13, 2025Incorrect Measurement; Incorrect Measurement

  ERRATIC AND UNRELIABLE MEASUREMENTS ON ONE PATIENT: -12 + 360 ICP VALUES DISPLAYED. REPLACEMENT WITH A SECOND CATHETER: PROBLEM PERSISTS. THIRD CATHETER THAT FUNCTIONED NORMALLY AND WAS STILL IMPLANTED ON FRIDAY (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202270 ↗
• MalfunctionJun 13, 2025Incorrect Measurement; Failure to Calibrate; Incorrect Measurement; Failure to Calibrate

  ERRATIC AND UNRELIABLE MEASUREMENTS ON ONE PATIENT: -12 + 360 ICP VALUES DISPLAYED.REPLACEMENT WITH A SECOND CATHETER: PROBLEM PERSISTS. THIRD CATHETER THAT FUNCTIONED NORMALLY AND WAS STILL IMPLANTED ON FRIDAY (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202222 ↗
• MalfunctionMay 14, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DEFECTIVE FIBER, INTERFERENCE WHEN PLUGGED INTO MAINS. SIGNAL ARTIFACT/NOISE. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. DEVICE EXPLANTATION. NO CLINICAL SITUATION IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019164 ↗
• MalfunctionApr 30, 2025Incorrect Measurement; Incorrect Measurement

  TWO PSO-PBT CATHETERS WERE IMPLANTED IN A PATIENT ON (B)(6) 2025. AFTER INSERTION, THE RESULT WAS NEGATIVE. THE ICP VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION DURING CLINICAL FOLLOW-UP; THE ICP IS NOT FUNCTIONING. ONE CATHETER WAS RETAINED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932983 ↗
• MalfunctionFeb 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2025, AFTER REMOVING A SUBDURAL HEMATOMA (BILATERAL) FROM A MAN IN HIS 50S WHO HAD SUSTAINED A HEAD INJURY IN A FALL, A PSO-PBT WAS INSERTED USING A TUNNELING TECHNIQUE. 5 DAYS OF ICT/ICP MONITORING WAS PERFORMED, AND ON (B)(6) 2025, A DOCTOR, THE PRIMARY SURGEON, ATTEMPTED TO REMOVE IT. DURING THE REMOVAL PROCEDURE, A PORTION OF THE CATHETER GOT CAUGHT IN THE SURGICAL FIELD, AND THE CATHETER ITSELF COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21383531 ↗
• MalfunctionJan 31, 2025Signal Artifact/Noise; Signal Artifact/Noise

  ON (B)(6) 2025, FOCH FOUNDATION REPORTED INTERFERENCE ON THE PRESSIO MONITOR. THE PATIENT WAS NEVERTHELESS MONITORED. ON (B)(6) 2025, THE CATHETER WAS STILL IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282327 ↗
• MalfunctionJan 24, 2025Signal Artifact/Noise; Signal Artifact/Noise

  WHEN THE MONITOR IS CONNECTED TO THE ELECTRICAL SECTOR, THE CURVE BECOMES TOTALLY UNREADABLE DUE TO INTERFERENCES. THE CURVE IS ALSO UNREADABLE WHEN THE MONITOR IS CONNECTED TO THE HOSPITAL'S CORRUGATED ELECTRICAL NETWORK.

  Patient problems: Idiopathic Intracranial Hypertension

  MAUDE report 21227650 ↗
• MalfunctionNov 18, 2024Unstable; Unstable

  THE CATHETER IS NOT FIXED IN THE BOLT WHEN IT IS IN HOLDING POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704053 ↗
• DeathNov 18, 2024Unstable; Unstable

  IMPLANTATION ON (B)(6)2024 ON A HYPERTENSIVE PATIENT WITH RIGHT DEEP INTRACEREBRAL HEMATOMA. THE POSITION OF THE ICP CATHETER WAS CONFIRMED BY CT SCAN ON (B)(6)2024. AGGRAVATION OF INTRACRANIAL HYPERTENSION AT DAY 4 DIAGNOSED 1 DAY LATE, DUE TO CATHETER MIGRATION IN THE BOLT. THE CATHETER SLIPPED OUT OF THE BRAIN AND NO LONGER CORRECTLY MEASURED ICP (ICP AT 5MMHG BUT NOT PULSATILE). THE PATIENT EXPERIENCED ARTERIAL HYPOTENSION WITH AN AVERAGE OF 50 MMHG, BRADYCARDIA AT 35 BPM AND BILATERAL AREACTIVE MYDRIASIS. CATHETER REPLACEMENT ON (B)(6)2024 SHOWING ICP AT 30MMHG. DEATH OF THE PATIENT OCCURS ON (B)(6)2024.

  Patient problems: Intracranial Pressure Increased

  MAUDE report 20703903 ↗
• MalfunctionAug 28, 2024Incorrect Measurement; Incorrect Measurement

  ARRIVAL ON 14/08, IMPLANTATION OF AN ICP CATHETER. ICP VALUE IS BETWEEN 15 TO 20MMHG. ANOTHER DAY, THE ICP VALUE RAISE TO 50MMHG WITH NO CHANGEMENT OF THE NEUROLOGICAL STATE OF THE PATIENT. THE ICP CATHETER WAS CHANGED AND NEW VALUE FOUND WAS 10MMHG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085838 ↗
• MalfunctionJun 4, 2024Incorrect Measurement; Incorrect Measurement

  ON (B)(6), THE PATIENT UNDERWENT RIGHT SKULL DECOMPRESSIVE CRANIECTOMY, DURAL TENSION-REDUCTION REPAIR, AND INTRACRANIAL PRESSURE PROBE IMPLANTATION DUE TO CEREBRAL HEMORRHAGE. ON THE (B)(6), INTRACRANIAL PRESSURE MONITORING SHOWED THAT THE VALUE FLUCTUATED GREATLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458071 ↗
• MalfunctionMar 15, 2024Incorrect Measurement; Incorrect Measurement

  ON FEBRUARY 18, ICP CATHETER HAS BEEN IMPLANTED AND IS NOT FUNCTIONAL. NEGATIVE NUMBER THEN 340. CHANGED 3 TIMES. ON FEBRUARY 19, ICP CATHETER REMOVED AND REPLACED BECAUSE THE BOLT DOES NOT FIX THE CATHETER. IMPLANTATION IN THE OTHER SIDE. ON FEBRUARY 21, NEW IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18911551 ↗
• MalfunctionJul 5, 2023Incorrect Measurement; Incorrect Measurement

  OUTLIERS AND A DIFFERENCE BETWEEN THE MONITOR AND THE SCREEN. REPLACEMENT OF ICP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17254802 ↗
• 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 13939420 ↗
• 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 13939412 ↗
• 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 13939407 ↗
• 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 13939288 ↗
• MalfunctionNov 16, 2020Use of Device Problem; Use of Device Problem

  A PART OF THE METAL SHAFT OF THE ICP DEVICE IS VISIBLE (OUTSIDE THE BANDAGE), AND THE ASSEMBLY IS SLIGHTLY CROOKED. AFTER CHECKING, IT APPEARS THAT THE BOLT IS VERY MOBILE, AND NO LONGER APPEARS TO BE ATTACHED TO THE PATIENT'S SKULL, THEN THE PRESSURE CURVE ON THE MONITOR IS LOST. EXPLANTATION OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10842272 ↗