Medtronic Inc. is recalling 65 units of the Abre Venous Self-expanding Stent System because there is a risk that the sterile packaging may have been breached. This recall affects three specific product models distributed worldwide, including 65 units in the United States and several other countries. Consumers and healthcare providers should identify if their specific batch numbers are affected and contact the manufacturer for further instructions regarding these medical devices.
If the sterile packaging is breached, the stent system may become contaminated with bacteria or other pathogens, potentially leading to serious infections or other complications when the device is used during a medical procedure.
Contact manufacturer for instructions
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.