FDA confirms Class I recall for thousands of stroke prevention devices

 YOU better be prepared to quiz your doctor on this.

I'm missing the reasoning behind even using these. The obvious solution is check if the Circle of Willis is complete, then close up the offending artery! You would still have 3 arteries supplying blood to the brain.

FDA confirms Class I recall for thousands of stroke prevention devices

Image courtesy of Boston Scientific.

The U.S. Food and Drug Administration (FDA) has confirmed a new recall for Boston Scientific’s Enroute Transcarotid Neuroprotection System and Enroute Transcarotid Neuroprotection System Plus. The recall was put in place due to a risk of arterial sheath tip separation or partial tip separation during use. One serious injury has been linked to this issue.

The FDA first warned the public about these risks in July as part of its Early Alert pilot program. The issue was still under investigation at that time. Now, the agency has reached its conclusion that this is a Class I recall, which means these devices are associated with a risk of “serious adverse health consequences or death.”  

This recall includes more than 115,000 units of the Enroute Transcarotid Neuroprotection System and nearly 50,000 units of the Enroute Transcarotid Neuroprotection System Plus. Customers with any of these devices on hand should stop using them right away and start the process of returning them to Boston Scientific. If customers know of any Enroute systems forwarded from one facility to the next, they should communicate with that facility about this concern.

Click here for more information from the FDA, including specific lot numbers.

Additional details about these devices

The Enroute Transcarotid Neuroprotection System and Enroute Transcarotid Neuroprotection System Plus are used by vascular surgeons and interventional cardiologists to perform transcarotid artery revascularization procedures. The Enroute system delivers transcarotid vascular access to clinicians and reduces the risk of stroke for patients presenting with carotid artery disease. It reverses blood flow in a way that keeps embolic debris away from the brain, providing clinicians with a minimally invasive alternative to carotid endarterectomy.

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