Z-0023-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2025
- Initiation Date
- August 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,019 units
Product Description
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. 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.
Distribution Pattern
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-414-159; UDI-DI 00850044399123; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.