NA 26020Recalls & reported problems
Medtronic Ps Medical, Inc. · CATH 26020 EDM VENT 2.6X4.9 TRANSLUC · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169498211), received between Jun 7, 2017 and Jun 29, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Leak/Splash” (2 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
Device problems
- Leak/Splash2
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER A VENTRICULAR DRAINAGE SURGERY, IN THE COURSE OF OBSERVING THE PATIENT'S CONDITION, THE PHYSICIAN FOUND THAT THERE WAS GAS IN THE PATIENT'S LATERAL VENTRICLE DUE TO THE DRAIN PIPE LEAKING ON (B)(6) 2017. ACCORDING TO THE REPORT, THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER DEVICE. REPORTEDLY, THE PATIENT'S STATUS AT THE TIME OF THE REPORT ALIVE-NO INJURY.
Patient problems: No Code Available
MAUDE report 6677872 ↗InjuryJun 7, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT'S PRIMARY DISEASE WAS CRANIOCEREBRAL TRAUMA. ACCORDING TO THE REPORT, POST-OPERATIVE OBSERVATION FOUND LEAKAGE OF THE ¿DRAINAGE TUBE¿ CAUSING THE PATIENT'S VENTRICLE TO BECOME A "CAVITY." REPORTEDLY, THE PHYSICIAN REPLACED WITH A NEW ¿TUBE,¿ AND THE PATIENT'S CURRENT STATUS WAS NORMAL.
Patient problems: No Code Available
MAUDE report 6620905 ↗
Other DEVICE, MONITORING, INTRACRANIAL PRESSURE devices
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- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 reports
- Becker® 46129Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall29 reports
- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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