Events

Recall of PLEURASEAL LUNG SEALANT SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CONFLUENT SURGICAL 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
    23961
  • Event Risk Class
    I
  • Event Initiated Date
    2010-10-12
  • 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
    Due to the unancitipated interim results of a study that was being conducted to evaluate the safety and efficacy of pleuraseal lung sealing system covidien has elected to discontinue commercial availability of this product. the study showed a higher than anticipated persistent air leak rate and inconsistent efficacy.

Device

PLEURASEAL LUNG SEALANT SYSTEM
  • Model / Serial
    Model Catalog: PLS-005 (Lot serial: ALL LOTS)
  • Product Description
    PLEURASEAL LUNG SEALANT SYSTEM
  • Manufacturer
    CONFLUENT SURGICAL INC.

Manufacturer

CONFLUENT SURGICAL INC.