The Abbott Vascular Absorb Bioresorbable Vascular Scaffold (BVS) System, used in heart procedures to improve blood vessel diameter, has been recalled due to findings of an increased risk of serious adverse events. Clinical studies indicated higher rates of myocardial infarction (heart attack) and scaffold thrombosis (blood clots in the scaffold) in patients receiving this device compared to those treated with metallic drug-eluting stents. A total of 590 units are affected by this recall.
Patients with this device may experience serious complications including heart attacks and blood clots because the scaffold may not perform as intended. These events can be life-threatening and may require urgent medical intervention.
Clinical follow-up
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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