# FDA recall Z-2334-2021

> **Northeast Scientific Inc.** · Class II · device recall initiated 2021-04-26.

## 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

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2334-2021
- **Recalling firm:** Northeast Scientific Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-26
- **Report date:** 2021-09-01
- **Termination date:** 2022-03-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waterbury, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2334-2021

## Citation

> AI Analytics. FDA recall Z-2334-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2334-2021. Source: US FDA. Licensed CC0.

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