Boston Scientific Corporation is recalling 4,141 units of the WallFlex Esophageal Stent System and Agile Esophageal Over the Wire (OTW) Stent System because the delivery catheter tip may detach during a procedure. These medical devices are used to keep the esophagus open in patients with tumors or other obstructions. If the tip breaks off, it could lead to internal injury, complications during the medical procedure, or the need for additional surgery to remove the detached piece. This recall affects various models and sizes distributed worldwide, including nationwide in the United States, between specific lot numbers.
The delivery catheter tip can detach from the device during use, which may cause internal tissue damage or block the esophagus. If the tip remains inside the patient, it may require an additional medical procedure or surgical intervention to safely retrieve the detached component.
Quarantine and return affected devices.
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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