Spectranetics Corporation is recalling 1,239 Turbo-Elite Laser Atherectomy Catheters because the label on the outside of the product box does not match the label on the internal sterile pouch. These devices, including models 420-159, 420-006, 414-159, and 417-152, are used by medical professionals to treat blockages in human blood vessels. Because the labels do not match, there is a risk that a surgeon could select and use a catheter with the wrong size or specifications for a patient's procedure. No specific injuries have been reported, but you should contact your healthcare provider if you have concerns about a recent procedure involving these devices.
If the exterior box label does not match the internal pouch, a physician may unknowingly use a catheter with incorrect dimensions or settings. This could lead to procedural delays, ineffective treatment of the blockage, or potential injury to the blood vessel during the atherectomy procedure.
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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