Events

Recall of Guidant CONTAK RENEWAL 3 RF & 4 RF

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Guidant Corporation.

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
    36495
  • Event Risk Class
    Class 2
  • Event Number
    Z-0269-2007
  • Event Date Posted
    2006-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48748
  • 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
    Shock effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. while no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed.
  • Action
    An Important Medical Device Information letter, dated 10/09/2006 was sent to physicians following patients with a potentially affected device. The letter describes the issue, provides for a projected rate of occurrence, and provides recommendations. An October 9, 2006 Product Advisory Letter, beginning October 30, 2006, was also sent to provide an update that further laboratory testing and analysis indicates that the nominal probability of malfunction is higher than their earlier prediction. Non-implanted devices have been retrieved.

Device

Guidant CONTAK RENEWAL 3 RF & 4 RF
  • Model / Serial
    Model H210, serial numbers: 204765, 204766, 204767, 204769, 204770, 204771, 204772, 204773, 204774, 204777, 204784, 205492, 205494, 205495, 205497, 205498, 205504, 205507, 205512, 205523, 205525.   Model H215, serial numbers: 703984, 703985, 703986, 704415, 704417, 704418, 704421, 704422, 704423, 704424, 704425.   Model H217, serial numbers: 704509, 704531, 704534, 704545, 704547, 704550, 705267, 705294, 705335, 705350.   Model H219, serial numbers: 203320, 203344, 203355, 203377, 203382.   Model H230, serial numbers: 201149, 201150, 201151, 201152, 201153, 201154, 201155.   Model H239, serial numbers: 650451, 650453, 650454.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution ---- including states of CA, FL, GA, IA, IL, KY, MA, MO, NJ, NY, OH, PA, TX and countries of Italy, Netherlands, Sweden, United Kingdom.
  • Product Description
    Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Manufacturer Address
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA