Events

Field Safety Notices about LeVeen Needle Electrodes – 5.0cm

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Boston Scientific.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2009-08-14
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/leveen-needle-electrodes-5.0cm---important-safety-information-from-boston-scientific&id=60d1f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
  • Extra notes in the data
    3rd Party Publications
  • Reason
    Background information or related documents: boston scientific corporation is conducting a medical device recall of the leveen™ needle electrodes – 5.0cm. boston scientific has become aware that during a procedure, the umbrella of the leveen™ needle electrode – 5.0cm may become detached from the core wire. the potential clinical effects of this product issue are bleeding or soft tissue trauma which may require intervention. to date there has been one reported complaint for this issue. further information is available in the field safety notice below. important safety information - leveen needle electrodes – 5.0cm.

Device

LeVeen Needle Electrodes – 5.0cm
  • Model / Serial
  • Product Description
    LeVeen Needle Electrodes – 5.0cm - Important Safety Information from Boston Scientific
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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
    HPRA