CereLink ICP Extension Cable Recalled for Out of Range Readings
Integra LifeSciences is recalling CereLink ICP Extension Cables due to a design defect causing out of range readings. The Class I recall affects 4,941 units distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall indicates potential for serious adverse health consequences. An intracranial pressure monitor malfunction providing inaccurate readings could directly affect patient diagnosis and treatment decisions.
Plain-English summary
Integra LifeSciences Corp. is expanding a recall to include all CereLink ICP Extension Cables (Model No. 826845). The cables are used with the Codman CereLink Intracranial Pressure Monitor. An original recall of the Cerelink was initiated in June 2022; this expansion adds the extension cables to that recall.
The extension cables may malfunction and produce out of range pressure readings from the intracranial pressure monitor. Inaccurate readings could affect patient diagnosis and treatment decisions. This is classified as a Class I recall by the FDA due to the potential for serious patient impact.
Approximately 4,941 extension cable units have been distributed to facilities throughout the United States and internationally to Australia, New Zealand, Canada, and Europe/Middle East/Africa.
Integra LifeSciences is implementing a corrective design change to the extension cables. Healthcare providers should discontinue use of affected cables and contact the manufacturer for replacement units. All lot numbers of the extension cable are affected (UDI-DI 10381780520665).
The recalled product
- Product
- CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device
- Affected units
- 4,941
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 10381780520665 All lots distributed
Distribution
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