Medical Device Recall: NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including
Northeast Scientific Inc. · August 29, 2025
Reason for Recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Product Description
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. 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.
Distribution
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
States Affected
NATIONWIDE
Quantity Affected
616 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0024-2026
Status: ongoing
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