AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, ...

FDA Device Recall #Z-2444-2019 — Class II — June 27, 2019

Recall Summary

Recall Number Z-2444-2019
Classification Class II — Moderate risk
Date Initiated June 27, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Angiodynamics, Inc.
Location Queensbury, NY
Product Type Devices
Quantity 109

Product Description

AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012

Reason for Recall

The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from being used.

Distribution Pattern

The products were distributed to the following US states: DC, IL, IN, MI, NJ, TN, TX, and WI.

Lot / Code Information

Lot 5456490; UPN H787114030120

Other Recalls from Angiodynamics, Inc.

Recall # Classification Product Date
Z-1391-2025 Class II IsoLoc Short Profile Prostate Immobilization Tr... Feb 4, 2025
Z-0770-2025 Class II AURYON LASER SYSTEM 100-120 VAC. Model Number: ... Nov 25, 2024
Z-2454-2024 Class II SOFT-VU KUMPE 5F X 65CM -Used for patients in n... Jun 18, 2024
Z-2453-2024 Class II SOFT-VU KUMPE 5F X 40CM -Used for patients in n... Jun 18, 2024
Z-2267-2024 Class II IsoLoc Prostate Immobilization Treatment Balloo... May 21, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.