Z-0770-2025Class II

AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100

Name: Z-0770-2025 AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Creator: Angiodynamics, Inc.
Published: 2024-11-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-11-25 / Open, Classified

FDA source

Angiodynamics, Inc. began a recall of AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100 on 2024-11-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0770-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-25
Posted: 2024-12-27
Recalling firm: Boston Scientific Corporation
Product: AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Product code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: AngioDynamics notified consignees on about 11/25/2024 via URGENT VOLUNTARY MEDICAL DEVICE CORRECTION letter. Consignees were instructed to located affected devices on hand, place the revised Operator's Manual with affected systems, remove and destroy the Operator s Manual that is presently with the Auryon Laser System, and notify any customers of the recall if the Auryon Laser System has been redistributed to another facility. Additionally, consignees were asked to complete and return the Reply Verification Tracking Form.
Quantity in commerce: 138 units
Distribution: US Nationwide distribution to the states of AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, RI, TN, TX, VA, WA, WI.
Product codes and lots: Product Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0770-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0770-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2024-12-27

Product code MCW

K241553Class IIAuryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd. / cleared 2024-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)