Events

Recall Or Safety Alert for Subset of 72 mono-coil defibrillation electrodes RELIANCE 4-FRONTTM, models 0682 and 0692

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 Cardiac Pacemaker Inc.

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
    2015-06-22
  • 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
    Possibility that the connector ring is not securely connected to the lead wire in certain RELIANCE 4-FRONTTM mono-coil defibrillation electrodes, manufactured by Cardiac Pacemaker Inc, USA, and clinical symptoms may occur.

Device

Subset of 72 mono-coil defibrillation electrodes RELIANCE 4-FRONTTM, models 0682 and 0692

Manufacturer

Cardiac Pacemaker Inc
  • 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
    AEMPSVFOI