Device Recall Guidant CONTAK RENEWAL 3

  • Model / Serial
    model H170, serial numbers: 509659, 509677, 509678,  509679, 509685, 509694, 509695, 509696, 509762, 509884,  509974, 510012   model H175, serial numbers: 512665, 512666, 512667, 512668, 512708, 512709, 512710, 512711, 512713, 512719,  512721, 512722, 512723, 512759, 512791, 512793, 513062,  513064, 513073, 513085, 513086, 513227   model H177, serial numbers: 506951, 506953, 506954,  506955, 506956, 506957, 506959, 506960, 506967, 506969,  506970, 506973, 506974, 507013, 507014, 507472   model H179, serial numbers: 508312, 508316, 508322,  508325, 508326, 508336, 508342, 508349, 508404
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide including Puerto Rico. Worldwide, including Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Portugal, Spain, Syrian Arab Republic, United Arab Emirates
  • Product Description
    Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA