Events

Recall of CYPHER SELECT PLUS SIROLIMUS-ELUTING CORONARY STENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    137878
  • Event Risk Class
    III
  • Event Initiated Date
    2009-05-15
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    In response to an increased number of complaints of cracks in the balloon inflation port hub of this coronary stenta field safety notice has been issued to remind users to follow inspection & preparation steps.

Device

CYPHER SELECT PLUS SIROLIMUS-ELUTING CORONARY STENT
  • Model / Serial
    Model Catalog: CRB33275 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB28350 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB28300 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB28275 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB28250 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB28225 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB23350 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB23300 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB23275 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB23250 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB23225 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB18350 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB18300 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB18275 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB18250 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB18225 (Lot serial: >100 LOTS CONTACT MFR); Model Catalog: CRB13350 (Lot serial: >100 LOTS
  • Product Description
    CYPHER SELECT + SIROLIMUS-ELUTING STENT
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.