Events

Recall of PillCam Express Delivery Device (Indicated for the transendoscopic delivery of the PillCam SB video capsule in patients who are unable to ingest the PillCam capsule or are known to have slow gastric emptying time)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Given Imaging Pty Limited.

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
    RC-2012-RN-01008-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-09-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01008-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Given imaging has received reports of failures of the pillcam during normal use and when the product was used in a manner that was not supported by its design specifications and tolerance's.
  • Action
    Given Imaging is recalling all affected devices and ceasing supply. There are alternative products available for customers.

Device

PillCam Express Delivery Device (Indicated for the transendoscopic delivery of the PillCam SB vid...
  • Model / Serial
    PillCam Express Delivery Device (Indicated for the transendoscopic delivery of the PillCam SB video capsule in patients who are unable to ingest the PillCam capsule or are known to have slow gastric emptying time)Part Numbers: FGS-0366 & FGS-0367Batch Numbers: 15720 to 18568Supplied between August 2010 and July 2012ARTG Number: 174813
  • Manufacturer
    Given Imaging Pty Limited

Manufacturer

Given Imaging Pty Limited
  • 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
    DHTGA