Integra LifeSciences Recalls Cerelink ICP Monitor Due to Reading Decline
Integra LifeSciences is recalling 189 Cerelink ICP Monitor units because they may show a progressive decline in intracranial pressure readings during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for inaccurate readings (progressive decline in ICP), which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Integra LifeSciences Corp. is recalling 189 units of the Cerelink ICP Monitor, Model Number 826820. The device is intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
The recall was initiated because there is a potential for a progressive decline in observed intracranial pressure (ICP) readings of the monitor during use. The affected products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were also distributed to the foreign countries of Australia and Belgium.
Healthcare facilities and users should stop using the affected devices and contact Integra LifeSciences Corp. for further instructions on the recall.
The recalled product
- Product
- Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 189
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)
- All systems
Distribution
Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · inaccurate reading
See all →- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
Similar recalls
- SevereCereLink ICP Monitor recalled for out-of-range pressure readings
FDA (Devices) · 2022-08-03
- SevereCereLink ICP Extension Cable Recalled for Out of Range Readings
FDA (Devices) · 2023-12-20
- ModerateIntegra Recalls Camino ICP Monitors Due to Speaker Malfunction
FDA (Devices) · 2015-05-27
- ModerateIntegra Recalls Camino ICP Catheters for MRI Safety Labeling
FDA (Devices) · 2014-07-23
- HighIntegra Camino Advanced Monitor Recalled for Reversed Pressure Display
FDA (Devices) · 2014-01-08
- HighIntegra Recalls Camino Intracranial Pressure Monitoring Catheters Due to Assembly Error
FDA (Devices) · 2015-06-24