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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000028749), received between Nov 22, 2024 and Jun 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE SURGEON DISCOVERED A CRACK IN THE TIP OF THE CATHETER DURING THE PLACEMENT PROCESS. THE EXTERNAL DRAINAGE CATHETER WAS PROMPTLY REPLACED TO COMPLETE THE SURGERY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22203630 ↗MalfunctionNov 22, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DURING THE OPERATION, THE PRODUCT PACKAGING WAS OPENED AND FOUND THAT THE TAIL END WAS DAMAGED. THE DEVICE WAS REPLACED IMMEDIATELY FOR USE. THERE WAS A PROCEDURE DELAY OF 20 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS NO ALLERGIES AND SMOKED FOR 40 YEARS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20756834 ↗
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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