FDA Class II Recall: INZONE DETACHMENT SYSTEM, REF: M00345100950 by Stryker Neurovascular — Recall Details

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Stryker Neurovascular and the affected product is described in FDA's record as: INZONE DETACHMENT SYSTEM, REF: M00345100950. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2552-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- INZONE DETACHMENT SYSTEM, REF: M00345100950 -- and the recall number Z-2552-2026. If it matches, stop using or distributing it and contact Stryker Neurovascular or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Stryker Neurovascular’s FDA history

Argus HQ has recorded 1 total FDA action tied to Stryker Neurovascular: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?

Stryker Neurovascular recalled INZONE DETACHMENT SYSTEM, REF: M00345100950. FDA's record states the reason for recall as: 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 (additional items listed in FDA's full record). The recall is logged under FDA recall number Z-2552-2026 with a Class.

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (INZONE DETACHMENT SYSTEM, REF: M00345100950) and recall number Z-2552-2026, then follow Stryker Neurovascular's recall instructions.

Has Stryker Neurovascular had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Stryker Neurovascular so far. Argus ingests new FDA enforcement records daily.

Related enforcement actions