# FDA recall Z-1819-2022

> **Angiodynamics, Inc.** · Class II · device recall initiated 2022-08-10.

## Product

VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM    Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.

## Reason for recall

OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention

## Distribution

US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.

## Key facts

- **Recall number:** Z-1819-2022
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-10
- **Report date:** 2022-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Queensbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1819-2022

## Citation

> AI Analytics. FDA recall Z-1819-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1819-2022. Source: US FDA. Licensed CC0.

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