Events

Recall of NANOKNIFE

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

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
    59825
  • Event Risk Class
    Class 2
  • Event Number
    Z-3258-2011
  • Event Initiated Date
    2011-04-04
  • Event Date Posted
    2011-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103817
  • 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
    Some units of nanoknife have the potential to deliver a shortened pulse width without indicating an error. the affected units contain a "gome" circuit board which may cause the generator to drift from the calibration points set at the time of manufacture.
  • Action
    AngioDynamics, Inc. sent a "NOTIFICATION OF MEDICAL DEVICE CORRECTION" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter instructs customers to review the measurement graphs (displayed on generator) after each delivery of energy, and to contact AngioDynamics Customer Service at 1-800-772-6446 if shortened pulses are detected. Contact your local sales representative or call Customer Service for any additional concerns or questions regarding this notice.

Device

NANOKNIFE
  • Model / Serial
    Batch/Serial Numbers: 00120508, 00090508, 00880909, 00371008, 00670709, 00850909, 00890909, 00780709, 00220708, 00300708, 00951009, 00900909, 00800709, 00260708, 00650709, 00690709, 00920909, 00930909, 00770709, 00130508, 01001009.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Australia, Germany, Israel, Italy, and Spain,
  • Product Description
    ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804 || Intended to remove tissue and control bleeding by the use of high- frequency electrical current (surgical ablation of soft tissue).
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • Manufacturer Address
    Angiodynamics, Inc., 603 Queensbury Avenue, Queensbury NY 12804
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA