Events

Recall of Device Recall Therapy Ablation Catheter

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
    59683
  • Event Risk Class
    Class 2
  • Event Number
    Z-3257-2011
  • Event Initiated Date
    2011-02-10
  • Event Date Posted
    2011-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103274
  • 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
    Cardiac Ablation Percutaneous Catheter - Product Code LPB
  • Reason
    The recall was initiated because st. jude medical has confirmed that the therapy ablation catheter, 4 mm tip thermistor quadripolar, were packaged with the incorrect instructions for use (ifu). to ensure accuracy of device labeling, st. jude medical is requesting that the incorrect ifu be replaced with the enclose, correct version.
  • Action
    St. Jude Medical sent an "important Medical Device Safety Information" letter dated February 22, 2011 to all affected customers. The letter includes: affected problem, reconciliation form and corrective action. Customers are asked to remove the incorrect Instructions for Use (IFU) and use the IFU provided in the letter, and to fill out and return the reconciliation form. For questions on this recall please contact the firm at (512) 329-1054 or (651) 756-2869.

Device

Device Recall Therapy Ablation Catheter
  • Model / Serial
    Model: 83726. Lots: 3167515, 3174474, 3183198, 3276124, K17381, K18242, K28491, K29692, K30008, and K30240.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of TN, MS, IN, MO, FL, WI, CA, and MT.
  • Product Description
    7 F Therapy Ablation Catheter, || 4 mm Tip Thermistor, || Model (Reorder #) 83726, || Description: 1304-7-25-XL-TH. || St Jude Medical Company || A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label.
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Manufacturer Address
    St Jude Medical, One St Jude Medical Dr, Saint Paul MN 55117
  • 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