CONTAK RENEWAL 4 AVT HE

  • Model / Serial
    Model Catalog: M177 (Lot serial: ); Model Catalog: H199 (Lot serial: ); Model Catalog: M170 (Lot serial: ); Model Catalog: M175 (Lot serial: ); Model Catalog: H190 (Lot serial: ); Model Catalog: H195 (Lot serial: ); Model Catalog: H197 (Lot serial: ); Model Catalog: M179 (Lot serial: )
  • Product Description
    CONTAK RENEWAL 4 AVT HE
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    HC

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    all serial numers
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    worldwide. Including United States, Virgin Islands and countries such as Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Cyprus, Czech Republic, Denmark, Eygpt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Labanon, Luxembourg, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom and Venezuela.
  • Product Description
    CONTAK RENEWAL 4 AVT CRT-D (model no. M170 and M175) and CONTAK RENEWAL 4 AVT HE CRT-D (model no. M177 and M179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, 4100 Hamiline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 4 AVT devices provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer
  • Model / Serial
  • Product Description
    AIMD: Dual-chamber implantable defibrillator<br>Single-chamber implantable defibrillator
  • Manufacturer