VENTAK PRIZM

Manufacturer

  • 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
    SATP

17 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial number range 118626 - 243772 includes ICDs manufactured prior to November 13, 2002. This range includes all affected devices but may include some unaffected devices.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide. Including United States and countries such as: Arab Emirates, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechoslovakia, Denmark, Finland, France, Germany, Hong Kong, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Polynesia, Portugal, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Uruguay, Venezuela
  • Product Description
    Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. VENTAK PRIZM 2 ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy.
  • Manufacturer
  • Model / Serial
    all serial numbers
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide. In addition to the US other countries include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Turkey, US - Virgin Islands and United Kingdom.
  • Product Description
    VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
  • Manufacturer
  • Model / Serial
    model 1860, serial numbers: 144889, 144891, 144893 thru 144903, 144926, 144927, 144930, 144932, 144942, 144946, 144947, 144950, 144955 thru 144957, 144959, 144965 thru 144979, 144981, 144983, 144985 thru 144989, 144991, 144994, 145000 thru 145005, 145009, 145012, 145013, 145015 thru 145028, 145030 thru 145044, 145050 thru 145053, 145055, 145056, 145058 thru 145061, 145065 thru 145069, 145071 thru 145078.   model 1861, serial numbers: 266473, 266475, 266477, 266478, 266480 thru 266483, 266485, 266487, 266488, 266492 thru 266494, 266496 thru 266506, 266510, 266511, 266516, 266518 thru 266521, 266523, 266525 thru 266527, 266532, 266533, 266535, 266536, 266553 thru 266557, 266561, 266576 thru 266578, 266580, 266582 thru 266587, 266608, 266617, 266632, 266637, 266641, 266663, 266665, 266668, 266671, 266676, 266684, 266685, 266694 thru 266696, 266699, 266702, 266705 thru 266712, 266714 thru 266728, 266732 thru 266741, 266744 thru 266749, 266753, 266764, 266769 thru 266775, 266777, 266779, 266780, 266782, 266784, 266786 thru 266794, 266796 thru 266798, 266802, 266803, 266805, 266807, 266812, 266820, 266823, 266824, 266829, 266832, 266833, 266835 thru 266837, 266839, 266841 thru 266843, 266849 thru 266857, 266859 thru 266863.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide- USA and Antigua Barbuda, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Micronesia, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela
  • Product Description
    Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Quantities Distributed by model are as follows: VENTAK PRIZM VR model 1860 = 67; DR model 1861 = 108.
  • Manufacturer
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Active implantable medical devices
  • Manufacturer
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