Events

Recall of Symphony DR and ELA Rhapsody DR

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
    34003
  • Event Risk Class
    Class 2
  • Event Number
    Z-0266-06
  • Event Initiated Date
    2005-10-25
  • Event Date Posted
    2005-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42892
  • 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 Pacemaker Pulse-Generator - Product Code DXY
  • Reason
    Through post-market surveillance, ela medical has observed that a no-output condition could occur in a limited number of symphony or rhapsody pacemakers. the no-output condition could occur due to metal migration caused by a specific manufacturing process.
  • Action
    A Dear Doctor letter, dated 10/25/05, was sent to all affected doctors. The letter describes the failures and mentions that pacemaker depend patients implanted with devices manufactured in the first group could require prophylactic replacement.

Device

Symphony DR and ELA Rhapsody DR
  • Model / Serial
    Symphony DR 2250 serial numbers: 238WG020, 243WG055, 246WG094, 246WG109, 250WG029, 303WG027, 303WG038, 303WG074, 303WG078, 306WG073, 309WG262, 314WG057, 315WG188 and 320WG220.   Rhapsody DR 2510 Serial numbers: 318WJ010, 318WJ060 and 318WJ061
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,
  • Product Description
    Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.
  • 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