Reported Jul 1, 2026 · Ongoing

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
    • 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.