Boston Scientific Corporation is recalling 14,724 units of its VersaCross and Torflex heart surgery kits due to a defect in the sterile packaging. The Tyvek layer of the sterile barrier pouch may have a hole, which could compromise the sterility of these medical devices. These kits are used in heart procedures to introduce catheters and wires or to create specific defects in the heart wall. If a non-sterile device is used, it can lead to serious complications for the patient.
A hole in the sterile barrier pouch can allow bacteria to contaminate the device. This poses a significant risk of systemic infection and sepsis, which can be life-threatening in a clinical setting.
Units affected: 14,724 (total event quantity).
Device approved and commercialized in Japan only.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.