Events

Recall of Encore 26 Inflation Device Single Pack

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Boston Scientific Pty 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
    RC-2017-RN-00795-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00795-1
  • 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
    Boston scientific has received reports of cracking with specific lots of encore 26 inflation device single packs. the device trays from these lots have the potential to crack under certain handling conditions, such as impact during shipment. this issue has been attributed to a change in the material used in the packaging process. use of an encore device with a cracked device tray during a procedure could result in patient infection if used within the sterile field. to date, no reports of patient harm have been received.
  • Action
    Boston Scientific is requesting that Customers: 1. Immediately check inventory and identify whether there are products with UPNs and lot numbers listed in Attachment 1 of the customer letter; 2. Inspect the device tray in the area highlighted above. If you identify any units with a cracked tray in your supply, immediately discontinue use and segregate affected units in a secure location; and 3. Complete the Reply Verification Tracking Form detailing identified affected units.

Device

Encore 26 Inflation Device Single Pack
  • Model / Serial
    Encore 26 Inflation Device Single PackUPN: H74904526011, M001151050, M00566670 and M0067101140 Multiple Lot NumbersARTG Number: 137086
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA