EDM 27637 (UDI 00643169497078)Recalls & reported problems
Medtronic Ps Medical, Inc. · EDM 27637 VCATH TRANS OD 4.9MM W/TROC · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169497078), received between Jul 7, 2017 and Jul 7, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AIR WAS TRAPPED WITHIN THE CATHETER AND COULD NOT BE ELIMINATED DURING THE PROCEDURE. ACCORDING TO THE REPORT, THE CATHETER WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6695195 ↗
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- CereLink™ 826850Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall2 deaths112 reports
- Duet® 46913Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall58 reports
- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 reports
- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- 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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