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
    43918
  • Event Risk Class
    II
  • Event Initiated Date
    2014-05-07
  • 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 has identified an increase in reports of partial tip separation for the pentaray nav and pentaray nav eco catheters. after conducting a root cause analysis biosense webster has identified an issue in the production process that can lead to an insufficient bond of the distal tip to the catheter shaft which could pose a safety risk to the patient.

Device

PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER
  • Model / Serial
    Model Catalog: D128208 (Lot serial: NOT SOLD IN CANADA); Model Catalog: D128207 (Lot serial: NOT SOLD IN CANADA); Model Catalog: D128211 (Lot serial: NOT SOLD IN CANADA); Model Catalog: D128210 (Lot serial: NOT SOLD IN CANADA); Model Catalog: D128205 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128201 (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 CATHETER
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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