BioGlide® 96118Recalls & reported problems
Medtronic Ps Medical, Inc. · CATH 96118 BIOGLIDE EDM VENT 35 CM · Class 2
All models of BioGlide (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000027988), received between May 15, 2023 and May 15, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (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
Device problems
- Complete Blockage1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2023Complete Blockage; Complete Blockage
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL VENTRICULAR DRAIN. IT WAS REPORTED THE DRAINAGE TUBE WAS BLOCKED, AND A NEW DRAINAGE TUBE WAS REPLACED TO COMPLETE THE CEREBROSPINAL FLUID TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931802 ↗InjuryMay 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL VENTRICULAR DRAIN. IT WAS REPORTED AFTER IMPLANTATION, THE TUBE WAS BLOCKED DURING THE NORMAL DRAINAGE PROCESS, AND THEN REPLACED WITH A NEW PRODUCT TO COMPLETE THE CSF DRAINAGE TREATMENT. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED DELAY TO PROCEDURE.
Patient problems: Unspecified Tissue Injury
MAUDE report 16931471 ↗
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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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