BioGlide 27705Recalls & reported problems
Medtronic Ps Medical, Inc. · CATH 27705 EDM NUM LNGTHMARK BIO 35CM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000875923), received between Jan 16, 2025 and Jan 29, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Fracture3
- Fluid/Blood Leak2
- Complete Blockage1
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2026Break; Fluid/Blood Leak; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT WHEN THE TUBE WAS OPENED FOR A PATENCY TEST, IT WAS FOUND TO BE DAMAGED AND LEAKING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209077 ↗InjuryJul 23, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER BEING USED AS A PROXIMAL COMPONENT TO DRAIN AND/OR MONITOR CEREBROSPINAL FLUID (CSF) FROM THE LATERAL VENTRICLE. IT WAS REPORTED THAT ON (B)(6) 2025, THE HYDROPHILIC COATED CATHETER WAS PLACED IN THE PATIENT, AND ON (B)(6) 2025, IT WAS DISCOVERED THAT THE PATIENT'S BED SHEET WAS WET, AND AT THE THREE-WAY CONNECTION OF THE EPIDURAL DRAINAGE TUBE, IT WAS DISCONNECTED CAUSING LIQUID LEAKAGE. THE CATHETER WAS REPLACED WITH ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574723 ↗MalfunctionMay 28, 2025Complete Blockage; Complete Blockage
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED THAT WHEN THE SURGEON WAS PERFORMING VENTRICULAR DRAINAGE, THEY FOUND THAT THE CATHETER WAS BLOCKED AT THE TIP. THE CATHETER WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. IT WAS INDICATED THE PRODUCT HAD CONTACT WITH A PATIENT WITH SYPHILIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095609 ↗MalfunctionJan 16, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE DISTAL END WAS CRACKED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21167575 ↗MalfunctionJan 16, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE DISTAL END WAS CRACKED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21167422 ↗
Other Device, monitoring, intracranial pressure devices
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- Exacta™ 46705Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall117 reports
- 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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