NEUROVENT-P 092946-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04057834026108), received between May 2, 2019 and Jan 20, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Sensing Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2023Unable to Obtain Readings; Unable to Obtain Readings

  FROM (B)(6) WE RECEIVED ON 2022-12-19 THE FOLLOWING INFORMATION ABOUT OUR CATHETER NEUROVENT-P (SN (B)(6): "TODAY WE PLACED A RAUMEDIC ICP CATHETER AND THE SURGEONS WEREN'T ABLE TO GET A READING, AFTER ATTEMPTING TO FIX THE PROBLEM WITHOUT REMOVING THE CATHETER IT WAS DECIDED TO REPLACE THE CATHETER WITH A NEW ONE. UPON REPLACING THE CATHETER IT WORKED PERFECTLY." AFTER CONSULTATION OF THE CLINIC WE GET ADDITIONAL INFORMATION THAT THE CATHETER WERE PLACED WITH TUNNELING SLEEVE IN ACCORDANCE OT THE IFU. THE PATIENT RECEIVED A NEW CATHETER DONE AT BEDSIDE. THE SECOND CATHETER WORKED AS EXPECTED. THE EVENT HAD NO CONSEQUENCE ON THE PATIENT'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213050 ↗
• InjurySep 14, 2022High Readings; High Readings

  FROM CLINIC (B)(6) WE RECEIVED INFORMATION THAT AN OF RAUMEDIC CATHETER NEUROVENT-P (SN (B)(4)) IS READING AN ICP VALUE OF 222MMHG. THE CATHETER WERE PLACED WITH TUNNELING SLEEVE. THE ICP READINGS WERE IMMEDIATELY HIGH AFTER IMPLANTING, SO PHYSICAN KNEW SOMETHING WAS WRONG. THEY TRIED TO TROUBLE SHOOT THE CATHETER WITHOUT SUCCESS. THE CLINIC DECIDES TO REPLACED CATHETER COMPLAINED BY ANOTHER CATHETER. THIS WAS DONE IN AN ADDITIONAL SURGERY. THE IMPLANTATION DID NOT ALTER THE PATIENTS CURRENT HEALTH STATE. THE ISSUE WITH THE CATHETER ICP READING HAD NO CONSEQUENCES FOR THE HEALTH OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417676 ↗
• InjuryMay 2, 2019Display or Visual Feedback Problem; Device Sensing Problem; Therapeutic or Diagnostic Output Failure

  SHORTLY AFTER SUCCESSFUL IMPLANTATION OF THE CATHETER ICP COULD NOT BE MONITORED ANYMORE. THE TROUBLESHOOTING SHOWED THAT NO MEASUREMENT WERE POSSIBLE WITH A DIFFERENT NPS2 OR NPS3. MASSAGE "PRESSURE SENSOR FAILURE" APPEARED ON THE MONITOR WHEN THE ZEROING PROCESS WERE DONE. A DEMO CATHETER WORKED FINE CONNECTING TO THE PATIENT MONITOR. THEREFORE THE DOCTOR TOOK THE PATIENT BACK TO THE OPERATING ROOM AND REPLACED THE CATHETER. THE HEALTH CONDITION OF THE PATIENT WAS NOT INFLUENCED BY THIS. CUSTOMER DESCRIBED THAT THE LOSS OF ICP SIGNAL OCCURRED DURING TRANSPORT TO ICU AFTER IMPLANTATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8572732 ↗