NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154....
FDA Recall #Z-0022-2026 — Class II — August 29, 2025
Product Description
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.
Reason for Recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Recalling Firm
Northeast Scientific Inc. — Waterbury, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
795 units
Distribution
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Code Information
Model No R-410-154; UDI-DI 00850044399062; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated