Events

Recall of PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER

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
    54061
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-19
  • 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
    Biosense webster is clarifying the contraindication language in the instructions for use (ifu) and product labeling relative to patients with prosthetic valves. the current language states: "[the] use of this catheter may not be appropriate for use in patients with prosthetic valves." biosense webster is updating the ifu to clarify the contraindication statement as follows: "do not use pentaray catheters in patients with prosthetic valves." this action is not a product removal.

Device

PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER
  • Model / Serial
    Model Catalog: D128207 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128209 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128210 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128211 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128212 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128208 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D128206 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128205 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128201 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128203 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128202 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128204 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    PENTARAY NAV ECO HIGH DENSITY CATHETERS;PENTARAY NAV HIGH DENSITY CATHETERS
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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