Device Recall DISCOVERY pacemaker

  • Modèle / numéro de série
    Affected devices may be contained in the following serial number ranges.  Model 1174: INITIAL RECALL Serial numbers 109017 thru 115660. EXPANDED RECALL serial numbers104205 thru 117464. Model 1175: INITIAL RECALL serial numbers 200731 thru 202199. EXPANDED RECALL serial numbers 200251 thru 202787 Model 1273: INITIAL RECALL serial numbers 315516 thru 324528. EXPANDED RECALL serial numbers 306216 thru 601338. Model 1274: INITIAL RECALL serial numbers 296080 thru 496546. EXPANDED RECALL serial numbers 404822 thru 498144. Model 1275: INITIAL RECALL serial numbers 500705 thru 501661. EXPANDED RECALL serial numbers 500211 thru 502015.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cyprus, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guyana, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Singapore,Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan ROC, Turkey, United Kingdom, Uruguay and Venezuela. EXPANDED RECALL additional countries include: China, Croatia, Korea. Lithuania, Madagascar, Maldives, Malta, Monaco, Nepal and Thailand.
  • Description du dispositif
    DISCOVERY (model nos. 1174, 1175, 1273, 1274 and 1275) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. DISCOVERY pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy. DISCOVERY pacemakers use an accelerometer that allows the pacing rate to adapt to the patient's changing metabolic demand as it responds to patient activity.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA