St. Jude Medical is recalling one specific lot of the Agilis NxT Steerable Introducer, affecting 129 units. The recall was initiated because the dilators in this batch are too short and will not extend outside the introducer sheath as intended. This manufacturing defect can prevent the device from functioning correctly during medical procedures. Because this is a specialized medical device, consumers should contact their healthcare provider or the manufacturer for further instructions.
If the dilator is too short to extend beyond the sheath, it may cause difficulty in accessing the heart or blood vessels, potentially leading to procedure delays or vascular injury during the insertion process.
Contact healthcare provider or manufacturer
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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