More than 500 Boston Scientific Innova stents have been recalled because some have failed to deploy properly when inserted into patients.
The Boston Scientific stent recall was announced on June 16 by the FDA, which classified the market withdrawal as a Class 1 medical device recall. The classification means that the FDA believes the defective stents carry a reasonable probability of causing serious injury or death to a patient.
The stents are used in the femoral and proximal popliteal arteries to treat symptomatic de novo or restenotic lesions. The recall comes following complaints to Boston Scientific that some of the stents failed to deploy when implanted in patients or only partially deployed.
Just when you think you've been having a really bad day, you get this call from your cardiologist....