Angiodynamics, Inc. is recalling 138 units of the Auryon Atherectomy Laser System (Model EXM001) because the device may fail to advance to the Activation (Ready) mode. If the system does not enter the ready mode, it can cause unexpected delays or interruptions during medical procedures. No incidents or injuries have been reported to date. Healthcare facilities should immediately stop using affected systems and contact the manufacturer to arrange for a return or correction.
Failure of the laser system to activate during a surgical procedure can lead to medical delays or interruptions that may compromise patient care. While no injuries have been reported, a device failure during a sensitive atherectomy procedure carries a moderate risk to patient safety.
Quantity: 138 units. Recall #: Z-0770-2025.
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.
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Sources: FDA iRES · Raw API Response
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