Neurovascular device recalled due to safety concerns
Stryker is recalling its InZone Detachment System due to a potential battery issue. The recall includes a total of nearly 45,000 devices.
The InZone Detachment System helps interventional radiologists and neurosurgeons perform neurovascular embolization procedures to treat intracranial aneurysms, and neurovascular abnormalities such as arteriovenous malformations and fistulae. The device is also indicated for arterial and venous embolizations in the peripheral vasculature.
The device, compatible with a variety of detachable coils, was designed to detect potentially challenging conditions and adjust as necessary. It includes a detachment button, a series of LED indicators and a cable connection port.
Why was this recall put in place?
There is a risk of these detachment devices experiencing “premature battery drain.” If this happens, they could either not power on at all or power on with limited effectiveness. In some cases, according to the recall, embolization procedures may need to be performed with an “alternative technique.”
The U.S. Food and Drug Administration (FDA) has categorized this issue as a Class II recall.
What should customers do?
Customers are urged to separate any affected devices so that they can be returned to Stryker’s California-based neurovascular division.
“If any of the subject devices have been distributed to other organizations, please forward a copy of this notice to the new users and provide contact details to recalling firm so new recipients can be informed appropriately,” according to the advisory.
Click here for additional information from the FDA about this Class II device recall.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.