FDA Issues Safety Alert for Revascularization Device Used in Acute Ischemic Stroke

The US Food and Drug Administration (FDA) issued a safety alert for the Penumbra 3D revascularization device (Penumbra, Inc.; Alameda, CA) because of a risk for the delivery wire breaking or separating during use.

The device is intended to restore blood flow or remove clots within a blood vessel in the brain during an acute ischemic stroke, specifically in patients who cannot receive intravenous tissue plasminogen activator therapy.

If breaking or separating of the delivery wire occurs, the fractured pieces could remain inside the patient’s bloodstream, and if attempts are made to remove the pieces, the stroke may actually become worse.

In addition, a patient’s blood vessels may remain blocked, or the patient may experience a complete stroke or death.

Healthcare professionals and patients can report adverse events related to the use of the Penumbra 3D revascularization device online.

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Penumbra 3D revascularization device by Penumbra: class I recall – wire material may break or separate during use. Silver Spring, MD: US Food and Drug Administration; July 21, 2017. Accessed July 24, 2017.