Events

Recall of Vermed, Inc Radiotransparent Defibrillation Electrodes

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
    65085
  • Event Risk Class
    Class 2
  • Event Number
    Z-1435-2013
  • Event Initiated Date
    2013-04-26
  • Event Date Posted
    2013-05-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118238
  • 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
    Electrode, pacemaker, temporary - Product Code LDF
  • Reason
    On 4/18/13 heartsync became aware of a recall from their wire/connector sub-assembly supplier which is used in the c100-physio electrodes. there were reports of equipment damage due to misalignment from tooling installed in august 2012. the result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
  • Action
    HeartSync sent an URGENT MEDICAL DEVICE RECALL notification letter dated April 26, 2013, to all consignees of Heart Sync for C100-Physio Radiotransparent Defrillation Electrodes. On April 29, 2013, an URGENT MEDICAL DEVICE RECALL notification was sent to Vermed Inc for the D304 Defrillation Electrodes . The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the affected product to the firm for full credit. Customers were asked to complete the form and send back via fax to 734-213-5640 or call 734-213-5530. For questions regarding this recall call 734-213-5530. .

Device

Vermed, Inc Radiotransparent Defibrillation Electrodes
  • Model / Serial
    Part Number: D304 and lot numbers:Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
  • Product Description
    Vermed, Inc Radiotransparent Defibrillation Electrodes || Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. || Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
  • 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