Cardioverter Defibrillator

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.”
  • Manufacturers representative
    Medilife s.a.l
  • Source
    RLMPH

78 devices with a similar name

Learn more about the data here

  • Model / Serial
    Claria and Wide CRT-D MRI, serial RPB603896S, RPB603895S
  • Product Description
    The CLARIA MRI system is indicated for use in patients with a high risk of sudden death due to ventricular tachyarrhythmias and who suffer from heart failure with ventricular dyssynchrony. The device is designed to provide atrial, ventricular or both atrial pacing, cardioversion and defibrillation for the automatic treatment of atrial, ventricular tachyarrhythmias, or both, which may endanger the patient's life.
  • Manufacturer
  • Model / Serial
  • Product Description
    aimd
  • Manufacturer
  • Model / Serial
    Model No. 355 572 Serial Nos. 78011361, 78011362, 78011364, 78011365, 78011376, 78011378-78011385, 78011389-78011414, 78011416-78011424, 78011426-78011430, 78011432-78011464, 78011466-78011491, 78011493-78011499, 78011600-78011617, 78011619, 78011621-78011639, 78011641, 78011643, 78011647-78011654, 78011656-78011660, 78011684-78011686, 78011689, 78011691, 78011692, 78011699-78011701, 78011704-78011708, 78011713, 78011720-78011723, 78011730-78011743, 78011745-78011758, 78011764-78011768, 78011779
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm.
  • Product Description
    Tachos DR - Implantable Cardioverter Defibrillator.
  • Manufacturer
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