Events

Recall of Device Recall PneumoSure

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

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
    73674
  • Event Risk Class
    Class 2
  • Event Number
    Z-1566-2016
  • Event Initiated Date
    2016-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144721
  • 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
    Insufflator, laparoscopic - Product Code HIF
  • Reason
    When operating the device in high flow mode (40l/min, 15 mmhg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0l/min and the red check gas supply symbol would appear on the display, immediately suspending insufflation.
  • Action
    Urgent Medical Device Recall letters were sent to domestic customers on March 28, 2016 by certified mail. Stryker International distribution sites were notified and are responsible for providing information to affected customers.

Device

Device Recall PneumoSure
  • Model / Serial
    HPUs affected lot numbers 0005051337-000505052795; PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide including Puerto Rico, China, Hong Kong, India, Japan, Korea, Romania, Vietnam, Singapore, Taiwan, Netherlands, Peru, Australia, Canada, Mexico, Argentina, Chile, Poland, South Africa, and Guatemala.
  • Product Description
    PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; || High pressure units (HPU) (40L and 45L). || Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 || The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA