Boston Scientific sent letters to customers of 500 of its Innova stents outside the United States, warning that it had received reports that the stent failed to deploy completely, according to a release from the FDA.
The letters, involving a Class I recall, the most serious level, were sent at about the same time as Boston Scientific's announcement that it was initiating a Class I recall of all of its iCross catheters due to "embrittlement of the catheter material."
The recall of Innova stents, used to treat lesions in the femoral artery and the adjacent proximal popliteal artery, does not affect stents that have already been implanted in patients.
Read the FDA release on Innova stents.
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