CanadaThe Stryker InZone® Detachment System (model/catalogue number M00345100950; affected lots/serial numbers with more than 10 numbers — contact the manufacturer to confirm) is affected. Some devices may experience premature battery drain, which can cause them not to power on, power on with faint audible and visual indicators, or be unable to detach a coil as intended; contact the manufacturer for additional information.
What's being recalled
Companies: Stryker Neurovascular, 47900 Bayside Parkway, Fremont, California, United States, 94538.
How to identify it
Affected products: InZone® Detachment System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M00345100950
The hazard
Stryker Neurovascular has identified an issue affecting certain lots of InZone® Detachment System devices. Stryker Neurovascular has observed that some devices may experience premature battery drain. When this occurs, the devices may:
• Not power on;
• Power on with faint audible and visual indicators;
• Be unable to detach a coil as intended.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States