Reported Jul 1, 2026 · Ongoing · Updated Sep 16, 2026
INZONE DETACHMENT SYSTEM, REF: M00345100950
Stryker Neurovascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Neurovascular · 47900 Bayside Pkwy · Fremont, CA · 94538-6515
Is this the product you have?
- INZONE DETACHMENT SYSTEM
- REFM00345100950
- Lot codes and dates
- UDI-DI04546540697950
- Lots
WMP133638WMP133871WMP133872WMP133988WMP133989WMP134016WMP134132WMP134133WMP134234WMP134235WMP134255WMP134256WMP134380WMP134381WMP134432WMP134433WMP134518WMP134519WMP134609WMP134610WMP134794WMP134795WMP134939WMP134940WMP135187WMP135243WMP135302WMP135314WMP135354WMP135355WMP135387WMP135417WMP135473WMP135475WMP135491WMP135492WMP135623WMP135720WMP135727WMP135807WMP135865WMP135897WMP136084WMP136107WMP136190WMP136200WMP136611WMP136642WMP136736WMP136748WMP136852WMP136894WMP136985
- Amount recalled
- 44,937
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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