Recall of Device Recall Alto MSP ICD and Alto 2 MSP 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Defibrillator, Implantable, Dual-Chamber - Product Code MRM
  • Reason
    Devices manufactured prior to august 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function.
  • Action
    A Dear Doctor letter dated 07/20/05 was sent describing the issue and providing recommendation that physicians follow-up with patients every 3 months. Patients who have frequent episodes of ventricular fibrillation or are pacemaker dependend may require prophylactic explantation or more frequent visits. A list of affected serial numbers was provided to each physician.


  • Model / Serial
    devices manufactured between April 2003 and August 2004. Model 617 serial numbers: 241XH059, 305XH005 and 305XH014.   Model 627 serial numbers: 330YA541, 348YA563, 348YA571,  348YA573, 348YA576, 350YA594, 407YA604, 407YA630,  407YA635, 407YA644, 411YA001, 411YA002, 411YA011,  411YA014, 411YA015, 411YA016 and 418YA029.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.
  • Product Description
    Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
  • Manufacturer


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