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Recall Observatory FDA recall evidence

Device product

NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901

Z-2334-2021

April 26, 2021

Class II

Product summary

Firm
Northeast Scientific Inc.
Event
Event 88345
Status
Terminated
Classification
Class II
Quantity
690 devices
Official record key
device-enforcement:Z-2334-2021

Official wording

Reason: 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.

Code information: Lots L0017886 through L0020553

Distribution pattern: US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.