Recall Z-1395-2022 ยท GWM Device, Monitoring, Intracranial Pressure
Integra LifeSciences Corp.
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
| Date | Jul 22, 2022 (initiated Jun 22, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | A recall notification titled 1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION, dated June 22, 2022, was sent by mail. This communicated troubleshooting techniques if an out-of-range reading is encountered when utilizing the Codman CereLink System, while Integra finalized a root cause investigation. A second notification, dated August 23, 2022, for this recall states that Integra is now conducting a removal of Codman CereLink ICP Monitors. Customers are asked to discontinue use of affected devices as soon as possible and remove the devices from service. If an affected device |
| Quantity | 1,210 units |
| 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, Nethe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210993 | CereLink ICP Monitor Integra Lifesciences Production Corporation, Apr 30, 2021 |