Events

Recall of US Safire Duo Ablation Catheter MediGuide Enabledand Cool Path Duo Ablation Catheter, MediGuide Enab

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St. Jude Medical.

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
    66597
  • Event Risk Class
    Class 2
  • Event Number
    Z-0174-2014
  • Event Initiated Date
    2013-10-11
  • Event Date Posted
    2013-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122676
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
  • Reason
    St. jude medical cardiovascular and ablation technologies division is performing a voluntary notification regarding selected batches of coolpath duo ablation catheter mediguide enabled products and safire duo ablation catheter mediguide enabled. these units were inadvertently shipped with the incorrect version of the instructions for use (ifu).
  • Action
    The firm, St. Jude Medical (SJM), sent a "Urgent Medical Device Notice" dated 11 October 2013 to its consignees. The letter described the problem, the product involved in the recall and the actions to be taken. The consignees were instructed to discard the IFU received with the batches and replace it with the IFU received in conjunction with the notification letter. SJM has determined that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU. If you have any questions, contact Vice President, Quality, at 651-756-5402.

Device

US Safire Duo Ablation Catheter MediGuide Enabledand Cool Path Duo Ablation Catheter, MediGuide Enab
  • Model / Serial
    Catalog Number A700244 Batch Number 4113241. Catalog Number A700240 Batch Number 4113242.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US distribution: KS, MA, UT,TX, KY, OH.
  • Product Description
    US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. || The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Manufacturer Address
    St. Jude Medical, 5050 Nathan Ln N, Plymouth MN 55442-3209
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA