CLASS I ONGOING Device recall · Reported 3 Aug 2022 · FDA Enforcement Report

CereLink ICP Monitor recalled by Integra LifeSciences

Integra LifeSciences is recalling CereLink ICP Monitor, distributed nationwide in the US. The recall was initiated on 22 Jun 2022 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI-DI- 10381780533778; All serial numbers.

Quantity recalled1,210 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1395-2022
FDA event ID: 90457
Recalling firm: Integra LifeSciences, Princeton, NJ
Classification: Class I
Status: Ongoing
Recall initiated: 22 Jun 2022
FDA classified: 22 Jul 2022
Reported: 3 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

22 Jun 2022	Recall initiated by company
22 Jul 2022	Classified by FDA	+30 days
3 Aug 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.

Where it was distributed

Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong Kong, Pakistan, Georgia, Saudi Arabia, Israel, South Africa, United Arab Emirates, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Switzerland, Spain, Sweden, Slovakia, and United Kingdom.

Nationwide Georgia

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI- 10381780533778; All serial numbers.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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