Events

Recall of Device Recall PillCam Express Delivery Device

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

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
    58137
  • Event Risk Class
    Class 2
  • Event Number
    Z-1748-2011
  • Event Initiated Date
    2011-03-08
  • Event Date Posted
    2011-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98450
  • 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
    endoscopic imaging device accessory - Product Code NEZ
  • Reason
    The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.
  • Action
    Given Imaging, Inc. consignees were notified via FedEx letter on/about 03/08/2011. They instructed to return all affected product. A Customer Response form with return instructions was included to be completed and returned to Given Imaging.

Device

Device Recall PillCam Express Delivery Device
  • Model / Serial
    FGS# 0366, Lot number: 14081, 13688, 14097, 14144, 13783 and 13504, UPC: 7290101362050 and FGS# 0367, Lot number: 13438, 13690, 13781, 13806, 14082, 14095, 14099.14145, 14249, 14370, 14568, 14508 and 14787, UPC: 7290101362067.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Nationwide, Canada, Germany Israel and Australia.
  • Product Description
    Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak).
  • Manufacturer
    Given Imaging Ltd.

Manufacturer

Given Imaging Ltd.
  • Manufacturer Address
    Given Imaging Ltd., 5555 Oakbrook Pkwy, Norcross GA 30093-6254
  • 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