Bolton Medical Inc. is recalling 21 units of the Relay Pro Thoracic Stent-Graft System because the stent-grafts inside the delivery systems are the incorrect size. This system is a sterile medical device used for endovascular repair and includes the stent-graft, instructions for use, and a patient tracking card. The affected devices were distributed in Arizona, Massachusetts, and Texas between November and December 2021. Consumers should immediately contact their healthcare provider or the manufacturer to confirm if their device is affected and to receive further instructions.
If an incorrectly sized stent-graft is implanted during surgery, it may fail to properly seal or support the blood vessel, which could lead to serious medical complications or the need for additional surgical procedures. No specific injuries were reported in the recall notice, but the mismatch between the labeled size and the actual device size poses a moderate risk during thoracic procedures.
Manufacturer correction via notification letter.
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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