Events

Recall of Device Recall OmniPod Insulin Management System

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

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
    72535
  • Event Risk Class
    Class 1
  • Event Number
    Z-0394-2016
  • Event Initiated Date
    2015-11-02
  • Event Date Posted
    2015-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141455
  • 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
    Pump, infusion, insulin - Product Code LZG
  • Reason
    Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
  • Action
    Insulet issued on 11/2/15 an URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes the problem that certain lots of the pod's needle failed to deploy or there is a delay in the deployment of the needle. Customers not responding to the email or Federal Express will receive additional mailing and/or follow up phone calls. Call Customer Care at 1-855-407-3729 if you have any questions regarding this Field Safety Notification.

Device

Device Recall OmniPod Insulin Management System
  • Model / Serial
    Lot Codes: L41908, L41910, F41935
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
  • Product Description
    OmniPod¿, Insulin Management System (OUS) || Catalog Number: 14810 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
  • Manufacturer
    Insulet Corporation

Manufacturer

Insulet Corporation
  • Manufacturer Address
    Insulet Corporation, 600 Technology Park Dr Ste 200, Billerica MA 01821-4126
  • Manufacturer Parent Company (2017)
    Insulet Corporation
  • Source
    USFDA