Events

Recall of Device Recall LigaSure Blunt Tip Laparoscopic Sealer/Divider

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Covidien 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
    57498
  • Event Risk Class
    Class 2
  • Event Number
    Z-0954-2011
  • Event Initiated Date
    2010-12-08
  • Event Date Posted
    2011-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96387
  • 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
    electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue.
  • Action
    The firm, Covidien, sent a "URGENT: PRODUCT RECALL" letter dated December 6, 2010, to the customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to remove product from inventory, immediately quarantine the product and return any remaining stock of the lots listed to: Covidien Energy-based devices, Attention: R82, Building 4/Receiving, 5920 Longbow Drive, Boulder, CO 80301. The customers were also instructed to complete and return the Customer Response Form immediately via mail (in the envelope provided) or fax to (303) 516-8307. To return any identified product for credit or replacement, contact Customer Service at 1-800-722-8772 Option 1. Should you have any medical questions concerning this recall, please contact your local sales representative or the Covidien Clinical information Hotline at (800) 255-8522 (option 1).

Device

Device Recall LigaSure Blunt Tip Laparoscopic Sealer/Divider
  • Model / Serial
    Lot No.: 188856, 190048, 190107, and 190307 through 193333 (88 lots).
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Australia, Canada, France, Germany, Japan, Puerto Rico, Singapore, and Uruguay.
  • Product Description
    Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301 || Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • Manufacturer Address
    Covidien LP, 5920 Longbow Dr, Boulder CO 80301-3202
  • Source
    USFDA