FDANews
FDAnews Device Daily Bulletin

Stryker Initiates Global Recall of Select Target Nano Neuro-coils

July 1, 2016

Stryker is initiating a voluntary global recall for a select number of Target Nano neurovascular coil over issues with substandard stretch resistance.

The sutures inside the coil that provide stretch resistance may have been damaged due to prolonged exposure to heat during manufacturing. If a coil is stretched during a procedure, the coil should be removed and replaced.

There is a remote potential of thrombus formation when the stretched coil is left exposed in the blood flow, but there are no long-term adverse events after a stretched coil is removed from the body, Stryker said. The issue does not affect patients with implanted coils.

View today's stories