Medtronic Perfusion Systems has recalled 420 units of the DLP Aortic Root Cannula with Flow-Guard (model REF 11012) used during cardiopulmonary bypass surgery. The recall was initiated because a misaligned seal on the device packaging could compromise the sterility of the cannula. While no injuries or incidents have been reported to date, using a non-sterile device during surgery could lead to serious medical complications for patients.
A misaligned seal creates a potential opening for contaminants to enter the device packaging, which may lead to a breach in sterility. If a non-sterile cannula is used in surgery, it could cause infection or other post-surgical complications.
Specifically for use in cardiopulmonary bypass surgery; Recall #: Z-0289-2025.
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 · FDA Press Release · 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.