Events

Field Safety Notices about Fem-Flex II Femoral Arterial Cannula

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by EDWARDS LIFESCIENCES.

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 Date Posted
    2014-05-06
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/05/06/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-fem-flex-ii-femoral-arterial-cannula/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    The manufacturer has received five reports in the last four months involving the separation of dilator tips on specific models of fem-flex ii arterial cannula sizes 16, 18 and 20 french. some of the reporeted vevents invovled separation of the tip of the dilator required through an interventional radiologic procedure. it was first reported in december of 2016 for lots manufacturet as early as march, 2011. the investigation determined that the dilator made specifically for the 16, 18 and 20 french sizes presented a hazard during use. based on the potential impact to patients, edwards is recalling the 16, 16 and 20 french sizes of the fem-flex ii aretrial cannulae that have not expired.

Device

Fem-Flex II Femoral Arterial Cannula
  • Model / Serial
    16 - DFEMII016AS, DIIFEMII016A, FEMII016A, FEMII016AS; 18 - DFEMII018AS, DIIFEMII018A, FEMII018A, FEMII018AS; 20 - DFEMII020AS, DIIFEMII020A, FEMII020A, FEMII020AS
  • Manufacturer
    EDWARDS LIFESCIENCES

Manufacturer

EDWARDS LIFESCIENCES