Angiodynamics recalls Auryon Laser System 100-120 VAC model EXM001 due to potential procedural delays during use. Affected units have specific product numbers and serial codes.
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Angiodynamics is recalling its Auryon Laser System 100-120 VAC model EXM001 because it may not advance to the Activation (Ready) mode during use, causing procedural delays. This could affect medical procedures requiring precise timing.
The system may not reach the Activation (Ready) mode during use, causing procedural delays. This could lead to extended procedure times or complications if the system fails to function as intended during critical medical procedures.
Medical professionals using the Auryon Atherectomy System for procedures are most at risk. Patients undergoing these procedures may experience delays in treatment.
Check for product number EXM-2001-1100 and model number EXM001. Serial numbers start with EXM followed by three digits.
Verify your product has model number EXM001 and product number EXM-2001-1100.
The recall is for potential procedural delays during use, not a safety hazard. The system may not advance to Activation (Ready) mode, but it does not pose a risk of injury.
Check for product number EXM-2001-1100 and model number EXM001. Serial numbers start with EXM followed by three digits.
The recall does not require immediate action. Check your product details to confirm if it is affected.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-0770-2025 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-0770-2025 from Angiodynamics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
