CERELINK 826852Recalls & reported problems
Medos International Sàrl · CERELINK ICP SENSOR Plastic Skull Bolt Kit For Intraparenchymal Procedure · Class 2
Data updated Oct 13, 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 10886704075455), received between Apr 21, 2022 and Jul 19, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
1 other recall cover devices cleared under the same FDA submission (K173192); they may or may not involve this specific model.
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
- Incorrect, Inadequate or Imprecise Result or Readings1
- Low Readings1
- No Device Output1
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.
InjuryJul 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A CERELINK MICROSENSOR WAS IMPLANTED AND CONNECTED TO A CERELINK MONITOR. THE CERELINK MONITOR STARTED DISPLAYING NEGATIVE VALUES THAT WERE NOT COMPATIBLE WITH THE PATIENT STATUS (THE PATIENT WAS FINE). THE VALUE WITH CERELINK MONITOR WAS -9. DUE TO THE NOT RELIABLE VALUES, THEY DECIDED TO MEASURE ICP WITH DVE AND WITH DVE THE ICP VALUE WAS 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15059148 ↗InjuryApr 21, 2022No Device Output; Low Readings; No Device Output; Low Readings
A FACILITY REPORTED A CERELINK MICROSENSOR WAS INSERTED WITH ICP EXPRESS AND AFTER A FEW MINUTES WITH POSITIVE ICP VALUES, THE ICP WENT DOWN TO -50 AND STOP MONITORING. EVEN SWITCHING ICP EXPRESS, AND REPLACING THE ZERO, VALUES WERE NOT DISPLAYED. THE SENSOR WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14167035 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K173192. One submission often covers many models, so check the product and lot details in each record.
- Z-1037-2026 · Dec 12, 2025 · Open, ClassifiedCodman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needl
Other DEVICE, MONITORING, INTRACRANIAL PRESSURE devices
- Exacta™ 27666Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall124 reports
- 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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