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 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.
The units come from five different lines of products, including the rHead, uHead, Sigmoid Notch, Remotion and Radio Capitellum devices. The recall covered 1,500 lots.
Stryker has notified the FDA and other regulatory bodies of the issue. The company has received 10 customer complaints related to the issue, but no adverse events have been reported.
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