Events

Recall of Boston Scientific Watchman Access System Access Sheath with Dilator

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Boston Scientific 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
    19083
  • Event Initiated Date
    2015-09-03
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • Reason
    The manufacturer has determined cross-threading of the hemostasis valve may occur if the valve is tightened with the dilator in place, potentially preventing subsequent sealing of the valve when desired., the manufacturer has issued a recall for product correction to reinforce existing directions for use (dfu) and provide further guidance regarding the correct use of the hemostasis valve in order to avoid cross-threading and to securely seal the valve, minimizing the potential for undesirable blood leakage.
  • Action
    Instructions for use to be updated

Device

Boston Scientific Watchman Access System Access Sheath with Dilator

Manufacturer

Boston Scientific Corporation
  • 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
    NZMMDSA