FDA Enforcement
Class II
Ongoing
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. 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.
Recall: Z-0020-2026
·
Reported October 8, 2025
Enforcement
- Recall Number
- Z-0020-2026
- Event ID
- 97524
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Northeast Scientific Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 8, 2025
- Initiation Date
- August 29, 2025
- Classification Date
- October 2, 2025
- Address
- 2142 Thomaston Ave, N/A, Waterbury, CT, 06704-1013, United States
Description
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. 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
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Code Info
Model No R-417-152; UDI-DI 00850044399093; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026
Distribution
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Quantity
165 units