Events

Recall of Device Recall AngelMed Guardian

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Enpath Medical, 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
    35983
  • Event Risk Class
    Class 2
  • Event Number
    Z-0121-2007
  • Event Initiated Date
    2006-07-18
  • Event Date Posted
    2006-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47306
  • 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
    lead adaptor - Product Code DTB
  • Reason
    The internal component (connector block) of the lead adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.
  • Action
    On July 7th, Enpath determined that a recall of Model 501206 and 501214 Adapters should be initiated and contacted customer via telephone and formally notified via letter on July 10, 2006. On July 14th, Enpath determined that a recall of Model 501204, Model 501205 and Angel Medical Model LA-001 Adapters should be initiated and two more consignees were notified via telephone on July 17th and both formally notified via letter on July 18, 2006. Enpath requested that customers segregate and return any product from the lot numbers listed in the letter, cease distribution of these devices and notify customers.

Device

Device Recall AngelMed Guardian
  • Model / Serial
    Model LA-001, Lot # W38932
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    CA, NJ, MN
  • Product Description
    Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian IMD. Manufactured for Angel Medical Systems, Inc. 1 Shelia Drive, Tinton Falls, NJ; Part No. 0208-2100-001, provided to Angel Medical Systems for International Clinical Studies; Sterile/ EO, Single Use.
  • Manufacturer
    Enpath Medical, Inc

Manufacturer

Enpath Medical, Inc
  • Manufacturer Address
    Enpath Medical, Inc, 7452 W 78th St, Minneapolis MN 55439-2513
  • Source
    USFDA