- The U.S. Food and Drug Administration (FDA) on Wednesday classified the recall of several hundred intracranial pressure monitors by Integra LifeSciences ( NASDAQ: IART ) as the most serious type.
- Integra ( IART ) in June recalled 388 CereLink ICP Monitors in the U.S. distributed between June 2021 to May 2022.
- The CereLink device monitors pressure in brain tissue and the cranium, which is used to track the health of patients with head injuries, stroke and other conditions.
- IART recalled the CereLink monitors after reports that the device could potentially display incorrect values for a patient's intracranial pressure and show out-of-range readings.
- The FDA on Wednesday classified the recall as a Class I recall , the most serious type as per its rules.
- The agency said it was aware of at least 68 medical device reports related to this issue, including reports of patient injury and one patient death. Integra ( IART ) determined that the death was unrelated to the monitor's malfunction.
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FDA labels recall of intracranial pressure monitors by Integra as most serious