Events

Recall of Device Recall Supreme Electrophysiology Extension Cable

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
    59392
  • Event Risk Class
    Class 2
  • Event Number
    Z-2955-2011
  • Event Initiated Date
    2011-06-01
  • Event Date Posted
    2011-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102589
  • 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
    Cable, electrode - Product Code IKD
  • Reason
    St. jude medical is recalling a single lot (3334664) of supreme electrophysiology extension cable which were packaged with a quadripolar cable instead of a hexapolar cable. st. jude medical has determined that the incorrectly labeled product poses no safety risk since the extension cable can be safely used with a corresponding quadripolar catheter but cannot be incorrectly connected to a hexap.
  • Action
    St. Jude Medical sent an "IMPORTANT MEDICAL DEVICE FIELD ADVISORY NOTICE" letter dated June 8, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to locate the affected product and to complete and return an attached SJM AFD Reconciliation Form. The form will be used to replace product and as documentation that the customers received the notice. Fax the completed form to 877-497-031. Contact the Director of Product Marketing at 512-329-1054 for questions regarding this notice.

Device

Device Recall Supreme Electrophysiology Extension Cable
  • Model / Serial
    Batch # 3334664
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-USA (nationwide) including the states of FL, NC, NY, and OR.
  • Product Description
    Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only, St Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55345. || Supreme Electrophysiology Extension Cable used to connect Electrophysiology catheters to external diagnostic or therapeutic equipment. The section indexing connector located a t the distal end of the cable will only connect to SMJ Electrophysiology catheters.
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Manufacturer Address
    St. Jude Medical, 14901 DeVeau Place, Minnetonka MN 55345
  • 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