Recall Z-2552-2026 ยท HCG Device, Neurovascular Embolization
Stryker Neurovascular
INZONE DETACHMENT SYSTEM, REF: M00345100950
| Date | Jun 24, 2026 (initiated Apr 6, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | 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 Busines |
| Quantity | 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, GU, MN, OK, NH, MD, ND, UT, HI, OR, LA, MS, KS, NM, ID, IA, VT and the countries of ARGENTINA, AUS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212455 | InZone Detachment System Stryker Neurovascular, Nov 16, 2021 |