Recall Z-0023-2026— Northeast Scientific Inc.
Class II · Ongoing
Class II FDA medical device recall by Northeast Scientific Inc., initiated 2025-08-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Potential for breaches in the sterile barrier packaging, compromising sterility assurance..
- Recalling firm
- Northeast Scientific Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-29
- Firm location
- Waterbury, CT, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.