Medical Device Safety and Recalls: Penumbra Inc. Recalls 3D Revascularization Device Due to Wire Material That May Break or Separate During Use

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Penumbra Inc. Recalls 3D Revascularization Device Due to Wire Material That May Break or Separate During Use

Penumbra Inc. is recalling the Penumbra 3D Revascularization device because there is a risk of the delivery wire breaking or separating during use. Fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the stroke worse. This can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death.

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