device recall
saveNortheast Scientific Inc. device recall (Cls II)
August 29, 2025updated 2mo ago
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NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. — Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. — Status: Ongoing
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