FDA-Device2026-07-01Class IIPROCESSING DEFECT

Stryker Neurovascular INZONE Detachment System recalled for premature battery drain risk

BATTERYNationwide distributionMedical devices

What this means

Stryker Neurovascular's INZONE Detachment System devices may experience premature battery drain, causing them to fail to power on, display faint indicators, or be unable to detach an embolization coil as intended. If a device fails during a procedure, medical staff may need to use an alternative technique to complete the intervention.

Contact your Stryker representative if you have affected lot numbers (WMP133638–WMP136748).
Check device battery status before use and have backup equipment available.
Report any device failures to Stryker and the FDA.

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

44,937

Manufactured in

47900 Bayside Pkwy, N/A, Fremont, CA, United States

Products

INZONE DETACHMENT SYSTEM, REF: M00345100950

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2552-2026

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