Events

Recall of Device Recall Implantable Defibrillation Lead

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group USA, 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
    64344
  • Event Risk Class
    Class 2
  • Event Number
    Z-0928-2013
  • Event Initiated Date
    2013-01-28
  • Event Date Posted
    2013-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115895
  • 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
    Defibrillator, implantable, dual-chamber - Product Code MRM
  • Reason
    Isoline defibrillation leads distributed may have internal insulation breach.
  • Action
    Sorin C.R.M., srl sent an Urgent Medical Device Field Safety Notice dated January28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return any unused products by certified mail with signed acknowledgment form, patients should continue to be monitored by their physician field reps during notification visit, and customers should make sure all personnel involved in the management of patients implanted with affected product are aware of the information described in the Field Safety Notice. Customers with questions should contact their local Sorin representative at 1-610-304-9728. For questions regarding this recall call 303-467-6222.

Device

Device Recall Implantable Defibrillation Lead
  • Model / Serial
    Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Morocco, The Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Ukraine, Uruguay and the United Kingdom.
  • Product Description
    Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. || These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Manufacturer Address
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA