INZONE DETACHMENT SYSTEM, REF: M00345100950

FDA device recall Z-2552-2026 · posted 2026-06-24 · Open, Classified

Recall details

Recalling firm

Stryker Neurovascular

Reason for recall

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.

Action taken

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

Root cause

Component design/selection

Status

Open, Classified

Product code

HCG

Quantity affected

44,937

Distribution

Worldwide - US Nationwide distribution including in the states of PA, AZ, FL, CA, IL, AK, NY, MI, NJ, WI, SD, KY, AR, TX, AL, TN, MO, MA, IN, NE, WV, MT, CT, NC, VA, NV, CO, DC, DE, OH, ME, GA, WA, SC

Date initiated

2026-04-06

Date posted

2026-06-24

Location

Fremont, CA

Related 510(k) clearances