INZONE DETACHMENT SYSTEM, REF: M00345100950
Recall
- Recall Number
- Z-2552-2026
- Event Number
- 98630
- Firm
- Stryker Neurovascular
- FEI Number
- 3008853977
- Product Code
- HCG
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- April 6, 2026
- Posted
- June 24, 2026
- Address
- 47900 Bayside Pkwy, Fremont, CA, 94538-6515
Description
INZONE DETACHMENT SYSTEM, REF: M00345100950
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 [email protected] For any additional information or questions, please contact [email protected] or US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: [email protected]
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, AUSTRIA, BELGIUM, BRASIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, KOREA, LATVIA, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH PACIFIC, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM.
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