Recall Z-0023-2026 ยท QTF Reprocessed Atherectomy Catheter
Northeast Scientific Inc.
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.
| Date | Oct 2, 2025 (initiated Aug 29, 2025) |
| Status | Open, Classified |
| Reason | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| Root cause | Process control |
| Action | 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) o |
| Quantity | 1,019 units |
| Distribution | US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.