Events

Recall of Device Recall VITALITY EL ICD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific CRM Corp.

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
    46297
  • Event Risk Class
    Class 2
  • Event Number
    Z-1514-2008
  • Event Initiated Date
    2008-01-07
  • Event Date Posted
    2008-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67156
  • 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 - Product Code LWP
  • Reason
    Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain icd and crt-d devices implanted subpectorally with the serial number facing the ribs. devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. this update identifies additional vitality icd.
  • Action
    An Urgent Medical Device Information Update to May 2006 Product Advisory, dated January 04, 2008, was sent to implanting physicians and physicians following implanted devices beginning Monday, January 07, 2008. The letter described a malfunction that can occur when the ICD is implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. The physicians were asked to review records to determine if an affected device was implanted subpectorally. An AP radiograph should be done to determine specific device orientation for subpectoral implants. If a subpectoral implant is in a susceptible orientation, consider repositioning or replacement for physically active patients who regularly need device therapy. Follow patients with susceptible devices at 3-month intervals.

Device

Device Recall VITALITY EL ICD
  • Model / Serial
    Devices that are implanted subpectorally with the serial number facing the ribs. Implant orientation is not reported to Boston Scientific CRM.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Worldwide: Bolivia, Panama, Iran, Saudi Arabia, Kuwait, United Arab Rep., Austria, Belgium, Cyrus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, India, Australia, New Zealand, Malaysia, Singapore, Hong Kong, China, Israel, Turkey, Thailand, and Canada.
  • Product Description
    VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Manufacturer Address
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA