Events

Recall of Device Recall Angeion Sentinel ICD

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
    31539
  • Event Risk Class
    Class 2
  • Event Number
    Z-0801-05
  • Event Initiated Date
    2005-01-25
  • Event Date Posted
    2005-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38111
  • 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
    A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750v charge times and disable the device's ability to report an end of life (eol) indicator due to excessive charge times unless the patient is receiving periodic 750v therapy shocks.
  • Action
    Angeion notified physicians responsible for managing each remaining implanted ICD, also provided them with programming means to change the automatic cap charging schedule, and to monitor and document the reprogramming process.

Device

Device Recall Angeion Sentinel ICD
  • Model / Serial
    AK630187, AK630131, AK630076, AK630290, AK630173, AK630115, AK730368, AK630130, AK630167, AK630099, AK630106, AK730377, AK730393, AK730443, AK730363, AK630157, AK730442, AK630026, AK630135, AK630102, AK630226, AK630142., AK730431, AK630185, AK630137, AK630230, AK630147, AK630015, AK630030, AK630197, AK630098, AK730448, AK630090, AK630265, AK630160, AK730455, AK730381, AK630146 OUS codes:AK630029, AK630043, AK630045, AK630046, AK630048, AK630055, AK630066, AK630067, AK630069, AK630072, AK630073, AK630075, AK630078, AK630080, AK630083, AK630101, AK630104, AK630108, AK630111, AK630112, AK630121, AK630129, AK630154, AK630155, AK630172, AK630174, AK630175, AK630178, AK630186, AK630199, AK630207, AK630216, AK630221, AK630223, AK630231, AK630247, AK630280, AK630281, AK630283, AK630284, AK630296, AK630297, AK630298, AK630299, AK730435, AK730439, AK730441.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.
  • Product Description
    Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
  • 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