device recall
saveNortheast Scientific Inc. device recall (Cls II)
August 29, 2025updated 2mo ago
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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. — Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. — Status: Ongoing
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