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.
Related Articles on Boston Scientific:
FDA Posts Four New Class I Medical Device Recalls
Boston Scientific Recalls iCross Coronary Catheters for Ultrasound Imaging
CEO of Boston Scientific Will Retire By End of Year
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