Events

Recall of Device Recall NanoKnife

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Angiodynamics Worldwide Headquarters.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60707
  • Event Risk Class
    Class 2
  • Event Number
    Z-0918-2012
  • Event Initiated Date
    2012-01-20
  • Event Date Posted
    2012-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106275
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Low energy direct current thermal ablation system - Product Code OAB
  • Reason
    Angiodynamics was marketing the nanoknife system with the ablation zone estimator feature in the us without fda clearance.
  • Action
    AngioDynamics sent an Urgent - Medical Device Correction letter dated December 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the User's Manual that was supplied with the generator when it was purchased. Instructions include discarding their current manual and troubleshooting guide. A replacement manual will be provided with the Field Safety Notice; the troubleshooting guide will not be replaced. Customers were instructed to complete the Reply Form and fax to AngioDynamics at 518-798-1360. If customers further distributed the affected product, they should inform those accounts of the field correction. Angiodynamics will also disable the AZE feature during a schedule service visit. For questions regarding this recall call 1-800-772-6446 or e-mail customerservice@angiodynamics.com.

Device

Device Recall NanoKnife
  • Model / Serial
    Batch codes: 00800709, 00880909, 00870909, 00630609, 00610609, 00470109, 00080508, 00180608, 00050508, 00460109, 00830709, 00240708, 00500209, 00930909, 00430109, 00480209, 00371008, 01210911, 00650709, 00670709, 00690709, 00850909, 00920909, 00820709, 00860909, 00890909, 00940909, 00780709, 00770709, 00760709, 00910909, 00790709, 00361008, 00750709, 00510209, 00450109, 00421208, 00490209, 00530209, 00600609
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101 || Intended use: the generator system with six outputs is indicated for surgical ablation of soft tissue.
  • Manufacturer
    Angiodynamics Worldwide Headquarters

Manufacturer

Angiodynamics Worldwide Headquarters
  • Manufacturer Address
    Angiodynamics Worldwide Headquarters, 14 Plaza Dr, Latham NY 12110-2166
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA