Events

Recall Or Safety Alert for peripheral self-expanding nitinol stent systems Pulsar-18 and Pulsar-35

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Biotronik, AG.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety Alert
  • Date
    2015-06-15
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Withdrawal from the market of certain batches of nitinol self-expanding peripheral stent systems Pulsar-18 and Pulsar-35, with a length of 200mm, manufactured by Biotronik, AG, Switzerland, due to the possibility of incomplete deployment.

Device

peripheral self-expanding nitinol stent systems Pulsar-18 and Pulsar-35

Manufacturer

Biotronik, AG
  • Manufacturer Parent Company (2017)
    Ms Holding Ii Se
  • Manufacturer comment
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    AEMPSVFOI