CODMAN® 826614Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® Cranial Access Kit · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780520375), received between Jun 18, 2024 and Jun 18, 2024 — classified as 1 injury.
1 FDA recall record name this device's identifier.
3 other recalls cover devices cleared under the same FDA submission (K914479); 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.
Reports received per month
Recalls naming this device
- Jan 21, 2022Terminated
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
Z-0817-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Patient problems
- Pneumocephalus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2024
CAP BREAKAGE FROM EVD (EXTERNAL VENTRICULAR DRAINAGE) SYSTEM RESULTING IN PNEUMOCEPHALUS.
Patient problems: Pneumocephalus
MAUDE report 19557126 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K914479. One submission often covers many models, so check the product and lot details in each record.
- Z-1614-2023 · Apr 11, 2023 · Open, ClassifiedCodman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Par
- Z-0706-2012 · Oct 25, 2011 · TerminatedCodman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xy
- Z-0707-2012 · Oct 25, 2011 · TerminatedCodman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and th
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.