Wilson-Cook Medical Inc. is recalling 3,599 Quantum TTC Biliary Balloon Dilators because the devices do not comply with design requirements and may experience balloon detachment during use. These medical devices are used by healthcare professionals to dilate strictures (narrowing) of the biliary tree. If the balloon detaches during a procedure, it may require additional endoscopic retrieval or could lead to bleeding, though in some cases the object may pass naturally through the body. Consumers should contact their healthcare provider or the manufacturer regarding these devices, which were distributed across the United States.
The balloon component can detach from the device during a medical procedure, potentially becoming an impacted or non-impacted foreign object in the patient's biliary system. This may require an additional invasive procedure to retrieve the detached piece and could cause internal bleeding or other complications.
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.
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Sources: FDA iRES · Raw API Response
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