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
    107721
  • Event Risk Class
    II
  • Event Initiated Date
    2011-07-04
  • 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
    Cordis is informing customers that there is a possibility of having units within the distributed lots of cypher select plus sirolimus-eluting coronary stent (catalog numbers crb33xxx and crb28xxx) that may not meet the cordis internal design specification for stent expansion uniformity (seu). the seu acceptance criterion for cypher product is less than 10 percent.

Device

CYPHER SELECT PLUS SIROLIMUS-ELUTING CORONARY STENT
  • Model / Serial
    Model Catalog: CRB28350 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CRB28300 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CRB28275 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CRB28250 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CRB33225 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CRB33350 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CRB33300 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CRB33275 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CRB33250 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CRB28225 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    CYPHER SELECT PLUS SIROLIMUS-ELUTING
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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