Events

Recall of AtriCure CryoICE cryo-ablation probe

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Atricure 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
    17831
  • Event Initiated Date
    2014-12-04
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: N Stenning & Co NZ Limited, C/O Bellingham Wallace, 470 Parnell Road, Parnell, Auckland 1052
  • Reason
    This recall has been initiated due to a packaging defect that could potentially compromise the sterility of this device. use of a non-sterile device could potentially cause permanent impairment or life-threatening injury. no injuries or deaths have been reported.
  • Action
    Product to be returned to supplier

Device

AtriCure CryoICE cryo-ablation probe
  • Model / Serial
    Model: Model: CRY02, Affected: Lot Numbers: 26500 through to 53607
  • Manufacturer
    Atricure Inc

Manufacturer

Atricure Inc