Events

Recall of Safire Duo Ablation Catheter MediGuide Enabled

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
    66574
  • Event Risk Class
    Class 2
  • Event Number
    Z-0187-2014
  • Event Initiated Date
    2013-10-11
  • Event Date Posted
    2013-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122638
  • 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 batched of safire duo ablation catheter mediguide enabled. these units have a cable connector configuration that is different than intended.
  • Action
    Consignees were sent a St. Jude Medical "Urgent Medical Device Notice" dated 11 October 2013. The letter was addressed to Cath lab manger / Risk Manger. The letter described the problem and the product involved in the recall. The letter stated that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU.

Device

Safire Duo Ablation Catheter MediGuide Enabled
  • Model / Serial
    Catalog Number A700238, Batch Number 4113243, 4152911. Catalog Number A700240, Batch Number 4113242, 4124985.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
  • Product Description
    Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. || Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
  • 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