SOPHYSA PSO-VTRecalls & reported problems

Sophysa · PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELING · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 11
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03760124131482), received between Jan 19, 2017 and Feb 10, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Apr 9, 2024Open, Classified
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.
Z-1825-2024 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

Device Sensing Problem7
Electrical /Electronic Property Problem3
Arcing1
Incorrect Measurement1
Obstruction of Flow1

Patient problems

No Clinical Signs, Symptoms or Conditions8
No Consequences Or Impact To Patient3

Recent adverse event reports

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

MalfunctionFeb 10, 2026Device Sensing Problem
A PSO-VT WAS INDICATED TO MONITOR ICP IN A CASE OF TRAUMATIC BRAIN INJURY. THE MONITOR SHOWED E001 AFTER THE IMPLANTATION. THIS INCIDENT LEADS TO ADDITIONAL SURGERY FOR THE PATIENT. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304498 ↗
MalfunctionAug 5, 2025Device Sensing Problem; Device Sensing Problem
A PSO-VT WAS INDICATED TO MONITOR ICP IN A CASE OF HYDROCEPHALUS. DURING FOLLOW-UP, AN ERROR E001 WAS OBSERVED. NO CLINICALS SIGNS OR SYMPTOMS WERE OBSERVED IN THE PATIENT. THE CATHETER FUNCTIONED FOR 12 HOURS. THIS INCIDENT LED TO THE PATIENT'S HOSPITALISATION BEING EXTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22715092 ↗
MalfunctionJul 2, 2025Device Sensing Problem; Device Sensing Problem
A PSO-VT WAS INDICATED TO MONITOR ICP IN A CASE OF TRAUMATIC BRAIN INJURY. DURING FOLLOW-UP, AN ERROR E001 HAS OCCURED ON THE MONITOR PSO-3000. THERE IS NO CLINICAL SIGNS OR SYMPTOMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382109 ↗
MalfunctionJan 15, 2024Arcing; Device Sensing Problem; Arcing; Device Sensing Problem
FOUR DAYS AFTER THE CATHETER WAS IMPLANTED, THE MACHINE SHOWED E001.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18510925 ↗
MalfunctionNov 27, 2023Device Sensing Problem; Device Sensing Problem
THE MACHINE SHOWED E001 AFTER THE CATHETER WAS IMPLANTED FOR 24 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18208260 ↗
MalfunctionSep 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CATHETER WAS IMPLANTED ON (B)(6), THE MACHINE SHOWED E001 ON (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17817504 ↗
MalfunctionMay 29, 2023Obstruction of Flow; Device Sensing Problem; Obstruction of Flow; Device Sensing Problem
ERROR IN PRESSURE MEASUREMENT AT ANY TIME FOR NO APPARENT REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17017175 ↗
MalfunctionMar 29, 2022Device Sensing Problem; Device Sensing Problem
DEVICE IMPLANTED ON (B)(6) 2022. THE SAME DAY, FOUR HOURS AFTER INITIAL SURGERY, THE MONITOR DISPLAYED ERROR E001. THE MONITORING COULDN'T BE MAINTAINED SO THE DEVICE WAS EXPLANTED. THERE WERE NO HEALTH COMPLICATIONS FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13939220 ↗
MalfunctionSep 1, 2020Incorrect Measurement; Incorrect Measurement
THE MONITOR DISPLAYED AN ERROR MESSAGE E001 AFTER IMPLANTATION OF THE PROBE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10475695 ↗
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 6272447 ↗
MalfunctionJan 19, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
PROBLEM WITH THE ICP MONITORING KIT : THE CATHETER SHOWED E002 ERROR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6263048 ↗

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

Device details

UDI-DI	`03760124131482`
Brand	SOPHYSA
Model	PSO-VT
Company	Sophysa
Product code	GWM · DEVICE, MONITORING, INTRACRANIAL PRESSURE
Class	Class 2
FDA submission	K062584
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 10, 2022

Device type (GMDN): Intracerebral sensor catheter, short-term

A flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use device.

Other DEVICE, MONITORING, INTRACRANIAL PRESSURE devices

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Codman Microsensor® 826631
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All DEVICE, MONITORING, INTRACRANIAL PRESSURE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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