Events

Recall of Device Recall Guidant, CONTAK RENEWAL 3/3RF

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
    56630
  • Event Risk Class
    Class 2
  • Event Number
    Z-0016-2011
  • Event Initiated Date
    2010-07-22
  • Event Date Posted
    2010-10-07
  • 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=94148
  • 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
    Implantable pulse generator, pacemaker (non-crt) - Product Code LWP
  • Reason
    Exposure to a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch to become permanently stuck in a closed position in certain boston scientific crt-ds and icds (contak renewal¿ 3 / 3 rf / 4 / 4 rf and vitality¿ he implantable defibrillators). this prevents delivery of programmed tachy therapy, and use of the patient triggered monitor feature. this issue may require.
  • Action
    Boston Scientific Issued Urgent Medical Device Correction and Physician Device Advisory Notice letters dated July, 2010 to customers identifying the affected devices, the issue prompting the recall, clinical implications, and actions to be taken by customers. Customers were instructed: 1) Physicians should continue routine follow-up sessions, and patients should be reminded to contact their clinic or go to the hospital emergency room immediately if they hear tones/beeps from their device. 2) In a hospital/clinic/surgery setting, if tones are heard upon magnet application but do not cease upon magnet removal, the device should be interrogated with a programmer and checked per normal standard of care. 3) In the United States, use of the LATITUDE remote patient monitoring system may help identify loss of daily measurements and thereby facilitate timely detection of a stuck reed switch. [NOTE 1: A pop-up message and/or LATITUDE alert do not appear for missing Daily Measurements. NOTE 2: Daily Measurements may be unavailable for reasons other than a stuck switch.] 4) Prophylactic explant is NOT recommended. 5) If a stuck magnetic switch is confirmed, program the Enable Magnet Use feature to Off, which ensures that programmed therapy will be provided to treat tachyarrhythmias. However, if Enable Magnet Use is programmed Off, a magnet will no longer inhibit tachy therapy, and the Patient Triggered Monitor feature will no longer be available. Do not routinely program Enable Magnet Use to Off in the absence of a confirmed stuck magnetic reed switch because the benefits of magnet use to disable tachy therapy in emergent situations outweigh the probability of patient harm associated with a stuck reed switch. In the US, Boston Scientific Cardiac Rhythm Management can be contacted at 800-227-3422, and in Europe, Boston Scientific Europe S.A. can be contacted at +32 2 416 7222.

Device

Device Recall Guidant, CONTAK RENEWAL 3/3RF
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: All States in the continental USA including PR and DC , but excluding VT, the countries of Canada, Mexico, and in Europe. ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRITISH VIRGIN ISLANDS, CANADA, CAYMAN ISLANDS, CHILE, COSTA RICA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, PORTUGAL , QATAR, SAINT KITTS & NEOIS, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM,VENEZUELA, URUGUAY, ZIMBABWE, IRAN.
  • Product Description
    Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219, Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 || CONTAK RENEWAL 4/4RF Models H190*, H195*, H197*, H199*, M170*, M175*, M177*, M179*, H230*, H235*, H239* || *Not available in the US
  • 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