Northeast Scientific Inc.: Medical Device Recall in 2021 - (Recall #: Z-2334-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 26, 2021

Date Posted: September 1, 2021

Recall Number: Z-2334-2021

Event ID: 88345

Reason for Recall:

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

Status: Terminated

Product Quantity: 690 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated