Events

Recall of Alto implantable cardioverter defibrillator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ela Medical Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30273
  • Event Risk Class
    Class 2
  • Event Number
    Z-0176-05
  • Event Initiated Date
    2004-10-21
  • Event Date Posted
    2004-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35594
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • Reason
    Alto implantable defibrillators models 614 and 615. these models can experience sudden no output, and early end of life characteristics due to metal migration in their controlling hybrids, causing high current drain leading to premature battery depletion.
  • Action
    The company observed occurrences of premature battery depletion and/or prolonged charge time for some Alto 614 and Alto 615 devices. The firm is requesting physician's assistance to monitor the performance of a limited number of implanted Alto 614 and 615 devices.

Device

Alto implantable cardioverter defibrillator
  • Model / Serial
    Model Numbers DR model 614, VR model 615
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Devices were received from the manufacturer in France. After received in the US, No devices were distributed from the US to foreign consignees. 95 physicians received the recalled product. ELA Medical has contacted physicians who follow patients implanted with the devices that are the subject of the correction. It should be noted that in many cases, the physician following the patient is not the physician who implanted the device. Because ELA is requesting assistance to monitor the performance of implanted devices, this notification is directed at the physicians who are following the patients.
  • Product Description
    Alto implantable cardioverter defibrillator
  • Manufacturer
    ela Medical Llc

Manufacturer

ela Medical Llc
  • Manufacturer Address
    ela Medical Llc, 2950 Xenium Ln N Ste 120, Plymouth MN 55441-2623
  • Source
    USFDA