Stryker Neurovascular recalls INZONE DETACHMENT SYSTEM

Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.

On 4/3/2026, recall notices were mailed to Supply Chain Management and Recall Coordinators who were asked to do the following: 1) Segregate the affected devices in a secure location for return to recalling firm. 2) If any of the subject devices have been distributed to other organizations, please forward a copy of this notice to the new users and provide contact details to recalling firm so new recipients can be informed appropriately. 3) Maintain awareness of this communication internally until all required actions have been completed within your facility. 4) Complete and return the Business Reply Form via email to nvfieldactions@stryker.com For any additional information or questions, please contact nvfieldactions@stryker.com or US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: NVCustomerCare@stryker.com

• FDA enforcement recordOfficial FDA database entry for Z-2552-2026
• FDA 510(k) clearance · K212455The device's official FDA premarket clearance record
• FDA device classification · HCGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.5950The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Stryker NeurovascularSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.