Events

Recall of Animas Vibe Insulin Infusion Pump and System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Animas 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
    69296
  • Event Risk Class
    Class 2
  • Event Number
    Z-0137-2015
  • Event Initiated Date
    2012-10-25
  • Event Date Posted
    2014-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130186
  • 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
    Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the vibe insulin infusion pump and system. animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability.
  • Action
    Animas initiated the notification to Distributors by letter, dated July 2012, and Patients and Health Care Professionals were notified by letter in September 2012. The delay in notifying patients and health care professionals was driven by the need to have sufficient inventory of replacement product on hand in order to meet anticipated demand before sending the letters.

Device

Animas Vibe Insulin Infusion Pump and System
  • Model / Serial
    Part Numbers  101200-57 100512-57 100510-02  100510-03  100510-04 100510-53 100510-56 100510-57 100510-63 100510-67 100511-02 100511-03 100511-04 100511-53 100511-56 100511-57 100511-63 100512-02 100512-02 100512-03 100512-04 100512-53 100512-56 100512-57 100512-63 100514-02 100514-03 100514-04 100514-53 100514-56 100514-57 100514-63 100515-02 100515-03 100515-04 100515-53 100515-56 100515-57 100515-63 101200-02 101002-03 101002-53 101002-56 101002-57 101002-63 101201-02 101201-03 101201-53  101210-56 101201-57 101201-63 101202-02 101202-03 101202-04 101202-53 101202-57 101202-63 101204-03 101204-04 101204-53 101204-57 101204-63 101205-03 101205-53 101205-56 101205-57 101205-63
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution in the countries of France, Italy, Sweden, and UK..
  • Product Description
    Animas Vibe Insulin Infusion Pump and System. || These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • Manufacturer Address
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380-3428
  • Source
    USFDA