FDA recall, , Moderate risk
Stryker Neurovascular Inzone Detachment System
The INZONE DETACHMENT SYSTEM may experience premature battery drain, causing it to not power on or be unable to detach a coil.
Summary by Recall Canary from the FDA notice
What happened
Stryker Neurovascular, of Fremont, California, recalled the Inzone Detachment System, REF: M00345100950, because embolization coil detachment system devices may experience premature battery drain.
This can cause the devices to not power on, power on with faint audible and visual indicators, or be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
The recall began April 6, 2026, and was added to the FDA's Enforcement Report on June 24, 2026, with distribution worldwide, including nationwide in the U.S. and in numerous other countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI, lot code and reference number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Inzone Detachment System
- UDI-DI
- 04546540697950
- Reference number
- M00345100950
- Lot code
- WMP133638
- WMP133871
- WMP133872
- WMP133988
- WMP133989
- WMP134016
- WMP134132
- WMP134133
- WMP134234
- WMP134235
- WMP134255
- WMP134256
- WMP134380
- WMP134381
- WMP134432
- WMP134433
- WMP134518
- WMP134519
- WMP134609
- WMP134610
- WMP134794
- WMP134795
- WMP134939
- WMP134940
- WMP135187
- WMP135243
- WMP135302
- WMP135314
- WMP135354
- WMP135355
- WMP135387
- WMP135417
- WMP135473
- WMP135475
- WMP135491
- WMP135492
- WMP135623
- WMP135720
- WMP135727
- WMP135807
- WMP135865
- WMP135897
- WMP136084
- WMP136107
- WMP136190
- WMP136200
- WMP136611
- WMP136642
- WMP136736
- WMP136748
- WMP136852
- WMP136894
- WMP136985
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Pennsylvania, Arizona, Florida, California, Illinois, Alaska, New York, Michigan, New Jersey, Wisconsin, South Dakota, Kentucky, Arkansas, Texas, Alabama, Tennessee, Missouri, Massachusetts, Indiana, Nebraska, West Virginia, Montana, Connecticut, North Carolina, Virginia, Nevada, Colorado, District of Columbia, Delaware, Ohio, Maine, Georgia, Washington, South Carolina, GU, Minnesota, Oklahoma, New Hampshire, Maryland, North Dakota, Utah, Hawaii, Oregon, Louisiana, Mississippi, Kansas, New Mexico, Idaho, Iowa, Vermont 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.
- Company
- Stryker NeurovascularFremont, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98630
- Recall number
- Z-2552-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
