A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Boston Scientific Innova Self-Expanding Stent System: Recall – Failure to Deploy. According to the Food & Drug Administration FDA’s MedWatch:
Failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent.
For more information on the drug or medical device recall or safety alert, read the Food & Drug Administration’s FDA’s drug or medical device recall or safety alert: Boston Scientific Innova Self-Expanding Stent System: Recall – Failure to Deploy.
To report an adverse reaction, problem or other issue with a drug or medical device, submit a drug or medical device complaint to the government at fda.gov or MedWatch.
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