Events

Recall of LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER

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
    152083
  • Event Risk Class
    III
  • Event Initiated Date
    2016-12-01
  • 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
    Manufacturer has received complaints reporting that reprocessed lf1637 or lf4318 ligasures experienced compatibility issues when connected to the ft10 generator. an "invalid instrument" error message may appear on ft10 generators with software revision 1.1.5.4 when devices without an rfid chip are connected to the generator. updates were made to the ifu to provide clarity on software compatibility.

Device

LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
  • Model / Serial
    Model Catalog: LF1637 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: LF4318 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER;LIGASURE IMPACT OPEN SEALER/DIVIDER
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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