CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Summary
The FDA issued a Class I for CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monito by Integra LifeSciences Corp.. Reason: Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extensio.
Details
Source
Device Recall
External ID
Z-1395-2022
Action Date
2022-08-03
Status
Ongoing
Category
device
Product Description
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Lot/Code Info: UDI-DI- 10381780533778; All serial numbers.
Quantity Affected: 1,210 units
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-22
Company
Princeton, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integra LifeSciences Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. have FDA actions?
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1395-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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