Stryker recalls INZONE Detachment System devices with premature battery drain causing failure to power on or detach coils, potentially requiring medical intervention.
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.
Stryker is recalling certain INZONE Detachment System devices that may experience premature battery drain. This can cause the device to fail to power on, show faint indicators, or be unable to detach coils, which might require medical intervention if the procedure must continue.
The devices may drain their batteries prematurely, leading to failure to power on or malfunctioning indicators. If the device cannot detach coils as intended, medical staff might need to switch to alternative techniques, potentially causing procedure delays or complications.
Medical professionals using the INZONE Detachment System for neurovascular procedures are most at risk. Patients undergoing procedures with these devices could face complications if the system fails during use.
Check for the model reference M00345100950 on the device. The recall includes specific lots listed in the UDI-DI code 04546540697950.
Verify if the device powers on normally with clear audible and visual indicators.
Reach out to Stryker Neurovascular for guidance on whether the device needs replacement or repair.
The devices may experience premature battery drain, causing failure to power on, faint indicators, or inability to detach coils, which could require medical intervention.
Check if the device powers on normally with clear indicators. If not, contact Stryker Neurovascular for assistance.
Look for the model reference M00345100950 and check the specific lots listed in the UDI-DI code 04546540697950.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2552-2026 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2552-2026 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
