Events

Field Safety Notices about NovaSil Silicon Single Lumen Embolectomy Catheter

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by LeMaitre Vascular GmbH.

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
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    This safety notice has been initiated due to the possibility that some products may have a compro- mised sterile barrier due to a packaging tube defect (pinhole at the sealed lower end). while the liklihood of a defect is low (0,01%), the loss of product sterility could lead to cross-contamination and infection. .

Device

NovaSil Silicon Single Lumen Embolectomy Catheter

Manufacturer

LeMaitre Vascular GmbH