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Recall Observatory FDA recall evidence

Device 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.

Z-0023-2026

August 29, 2025

Class II

Product summary

Firm
Northeast Scientific Inc.
Event
Event 97524
Status
Ongoing
Classification
Class II
Quantity
1,019 units
Official record key
device-enforcement:Z-0023-2026

Official wording

Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Code information: Model No R-414-159; UDI-DI 00850044399123; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.

Distribution pattern: US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for breaches in the sterile barrier packaging, compromising sterility assurance.