FDA Class I Recall: Stryker Trevo XP ProVue Retrievers

Megan Brooks

November 11, 2020

Stryker Neurovascular is recalling more than 1200 Trevo XP ProVue Retrievers because of a risk that the core wire may break or separate when the device is being retracted, the US Food and Drug Administration (FDA) has announced.

The Trevo XP ProVue Retriever is used to restore blood flow or remove blood clots in patients with acute ischemic stroke.

If the core wire breaks or separates when retracting, the device could be left inside the patient's blood vessel or tissue, causing serious problems, including bleeding, additional blockage of blood vessels, disability, and death, the FDA warns.

To date, 11 incidents of injury or illness and one death have been reported related to this problem with the device.

The FDA is categorizing the recall as class I, the most serious type.

A complete list of catalogue numbers and lot numbers for all 1258 recalled devices is on the FDA website.

The recalled devices were manufactured between July 22, 2019, and September 9, 2019, and were distributed between September 18, 2019, and July 7, 2020.

Stryker Neurovascular has sent a letter to all affected customers asking them to identify and set aside all affected product, to inform the company if any of the devices have been distributed to other organizations, to report any adverse events related to the recalled devices, and to complete Stryker's customer response form and email it to NVCustomerCare@Stryker.com.

The designated Stryker territory manager or sales representative will provide product return information. Customers with questions regarding this recall may contact Stryker Customer Care by email at NVCustomerCare@Stryker.com or by phone at 1-855-916-3876.

Healthcare professionals can report adverse reactions or quality problems they experience using the devices to the FDA's MedWatch program.

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