Events

Recall of Device Recall Valleylab Laparoscopic Handset

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by COVIDIEN MEDTRONIC.

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
    76384
  • Event Risk Class
    Class 2
  • Event Number
    Z-1836-2017
  • Event Initiated Date
    2017-01-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153021
  • 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
    Customer reports of the device handset continuing to operate after release of the activation button.
  • Action
    A recall was initiated on January 26, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.

Device

Device Recall Valleylab Laparoscopic Handset
  • Model / Serial
    E2750: 52990142X 52990142X 52990144X 52990144X 52990147X 52990147X 52990151X 52990151X 53250057X 53250057X 53250061X 53250061X 53250063X 53250063X 53250065X 53250065X 53610053X 53610053X 53610055X 53610055X 53610059X 53610059X 53610061X 53610061X 60240055X 60240055X 60240059X 60240059X 60240061X 60240061X 60240065X 60240065X 60520098X 60520098X 60520104X 60520104X 60870064X 60870064X 61220093X 61220093X 61220095X 61220095X 61220098X 61220098X 61300164X 61300164X 61540145X 61540145X 61540150X 61540150X E2750NSB: 52990145X 53250066X 61220096X 61540146X
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide - US Nationwide Distribution in the states of: AR AZ CA CO FL GA IA IL KS KY LA MA MI MN MO MS NC NE NM NY OH OR PA SC SD TN TX VA WA WV
  • Product Description
    Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB || Product Usage: || For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of 3625V.
  • Manufacturer
    COVIDIEN MEDTRONIC

Manufacturer

COVIDIEN MEDTRONIC
  • Manufacturer Address
    COVIDIEN MEDTRONIC, 60 Middletown Ave, North Haven CT 06473-3908
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA