Events

Recall of Device Recall Medstorm Adult Radiolucent LeadsOut Electrode

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heart Sync, Inc.

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
    57815
  • Event Risk Class
    Class 2
  • Event Number
    Z-1950-2011
  • Event Initiated Date
    2008-12-05
  • Event Date Posted
    2011-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97492
  • 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
    Multi-Function Electrocardiograph Electrode - Product Code MLN
  • Reason
    The "leads out" connector had bent pins which would not allow connection to the medtronic physio control defibrillator cable during a product demonstration.
  • Action
    The firm sent a recall notice to their distributors on 12/3/2008 asking them to quarantine product and return it to HeartSync. The letter stated that customers' current inventory would be exchanged for new product. Customers were to call 1-800-828-4681 to provide the necessary information.

Device

Device Recall Medstorm Adult Radiolucent LeadsOut Electrode
  • Model / Serial
    Lot Numbers: Y091008-13, Y091008-14, Y111208-13, and Y111208-14.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. || Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
  • Manufacturer
    Heart Sync, Inc

Manufacturer

Heart Sync, Inc
  • Manufacturer Address
    Heart Sync, Inc, 5643 Plymouth Rd, Ann Arbor MI 48105-9586
  • Manufacturer Parent Company (2017)
    Heart Sync, Inc
  • Source
    USFDA