Events

Recall of LASSO 2515 NAV ECO VARIABLE CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER CANADA LP.

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
    86577
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Stryker sustainability solutions has received an increase in reports indicating that an eeprom chip error code may occur when reprocessed 2515 nav eco variable electrophysiology (ep) catheters are used with carto? ep navigation systems. there have been no injuries reported as a result of this event.

Device

LASSO 2515 NAV ECO VARIABLE CATHETER
  • Model / Serial
    Model Catalog: D134301 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    REPROCESSED LASSO 2515 NAV ECO VARIABLE CATHETER
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC