NEUROVENT-PTO 095008-002Recalls & reported problems
Raumedic AG · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04057834028720), received between Apr 8, 2026 and Apr 8, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
- No Device Output1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2026No Device Output; Material Deformation
FROM OUR DISTRIBUTOR WE RECEIVED THE FOLLOWING DESCRIPTION OF AN EVENT TO ONE OF OUR CATHETER NEUROVENT-PTO ON (B)(6) 2026 AT (B)(6) HOSPITAL: "AS CATHETER WAS BEING PLACED IN PATIENT, IT COILED AND WAS NON-FUNCTIONAL. SUNY REPORTED THE INCIDENT THROUGH THEIR RECALLS TEAM WHO REPORTS TO ECRI." FOLLOW-UP INFORMATIONS WERE RECEIVED ON (B)(6) 2026 AND (B)(6) 2026: "DR. (B)(6) PLACED RAUMEDIC DRAIN IN PATIENT. UPON INSERTION ELEVATED ICPS WERE NOTED THEREFORE PATIENT REQUIRED MULTIPLE INTERVENTIONS TO HELP BRING ICPS DOWN. ON THE POST PROCEDURE CT THE CATHETER APPEARED TO BE "SQUIGGLED"/"COILED" PER DR. (B)(6). EVD WAS THEN PLACED TO CONFIRM ELEVATED ICPS WHICH DID IN FACT CONFIRM ELEVATED ICPS WERE TRUE. RAUMEDIC WAS REMOVED AND PLACED IN BIOHAZARD BAG TO BE ASSESSED AND SENT BACK TO MANUFACTURE FOR POSSIBLE DEFECT. NURSE MANAGER MADE AWARE OF THIS AS WELL." "BASED ON THE NOTES IT APPEARS THE EVD WAS PLACED LATER THAT NIGHT, NOT AT THE SAME TIME. RAUMEDIC WAS REMOVED AND REPLACED WITH EVD. THEY BELIEVED IT WAS NON-FUNCTIONAL BECAUSE THE ICP'S WERE SO HIGH. THEY DID GET A READING, SO THERE WAS FUNCTION JUST CONCERN WITH ACCURACY. RAUMEDIC WAS PLACED, NOTED TO HAVE HIGH ICP'S GREATER TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24813025 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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