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.
This recall is currently active, issued October 2, 2025. It was issued by Northeast Scientific Inc..
- Company
- Northeast Scientific Inc.
- Recall Initiated
- August 29, 2025
- Posted
- October 2, 2025
- Recall Number
- Z-0020-2026
- Quantity
- 165 units
- Firm Location
- Waterbury, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Distribution
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Lot / 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
Root Cause
Process control
Action Taken
Northeast Scientific notified consignees via an "URGENT: Medical Device Recall Notification" letter dated 8/29/2025 and email. Consignees were instructed to immediately discontinue use of affected products, quarantine and return any unused affected units, and complete and return the enclosed Recall Response Form, even if you no longer have any affected product. If product were further distributed, consignees were instructed to notify those customers immediately and ensure they also discontinue use and return the devices. Northeast Scientific will provide replacement product (if available) or credit for returned product. In addition, Northeast Scientific has initiated an investigation and is implementing corrective actions to prevent recurrence. If you have any questions or concerns, please reach out to your Northeast Scientific Sales Representative or contact us at Sales@nescientific.com or 203-756-2111.