Events

Safety Alert for OffRoad - Reintroduction Catheter - Record 10341350691 - Hazard Class II (Medium risk) - Technical Name: Catheters - Model H74939202100540 - Affected lots 16514006 (SCHEDULE OF DISTRIBUTION IN ANNEX)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific do Brasil Ltda.; Boston Scientific Clonmel Limited.

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
    Safety alert
  • Event ID
    1425
  • Date
    2014-09-18
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    According to the company, "affected lots do not have the potential of associated risks, because they are currently valid, without any risk to the patient, so there are no consequences of using these lots."
  • Reason
    The product of offroad reintroduction catheter is composed of two components, contained in an external cardboard box: the balloon catheter of posiconamento and the lancet of the microcatheter. the company has identified that the outer carton contains a validity period of two months beyond the actual expiration date. however, the actual expiration date of each of the components is presented correctly in their individual inner packages.
  • Action
    The company decided to collect the affected products - Pickup for return to the manufacturer. - Offroad Code 01-2014. (LETTER OF NOTIFICATION TO THE CLIENT IN ANNEX).

Device

OffRoad - Reintroduction Catheter - Record 10341350691 - Hazard Class II (Medium risk) - Technica...

Manufacturer

Boston Scientific do Brasil Ltda.; Boston Scientific Clonmel Limited
  • 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
    ANVSANVISA