CODMAN CERELINK 826822Recalls & reported problems
Cerenovus, Inc. · CODMAN CERELINK Replacement Power Supply · Class 2
Data updated Oct 16, 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 10886704081098), received between Dec 18, 2023 and Dec 18, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K183406); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
A FACILITY REPORTED A LIVE PIN OF POWER SUPPLY COUNTRY SPECIFIC ADAPTOR DISCONNECTED FROM ITS LOCATION. THE PIN HAS LIVE 230 VOLTS POTENTIAL. THE EVENT LED TO LESS THAN 30 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18344993 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K183406. One submission often covers many models, so check the product and lot details in each record.
- Z-0124-2020 · Sep 12, 2019 · Open, ClassifiedCerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitorin
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
- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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