Events

Recall of Enpath Lead Adapter

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

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
    53777
  • Event Risk Class
    Class 2
  • Event Number
    Z-0580-2010
  • Event Initiated Date
    2009-09-01
  • Event Date Posted
    2009-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86497
  • 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 adapter, permanent pacemaker electrode - Product Code DTB
  • Reason
    The silicone tubing of affected leads was processed outside of validated parameters. although the material remains biocompatible, test data regarding the performance characteristics are not available.
  • Action
    Customers were contacted by phone beginning 09/01/09. They were asked to hold product and determine if they had distributed any product. A written notification followed which identified the product, described the issue and asked for product to be returned. Product was distributed to two consignees and contained the following day. Questions are directed to the company at 612-559-2613.

Device

Enpath Lead Adapter
  • Model / Serial
    Serial numbers: 148236, 148237, 148238, 148239, 148240, 148241, 148242, 148243, 148036, 148038, 148039, 148040, 148041, 148042, 148043, 148044, 148045, 148046, 148047, 148048, 148049, 148050, 148051, 148052, 148053, 148054, 148055, 148056, 148057, 148058, 148059, 148060, 148061, 148063, 148064, 148065, 148066, 148067, 148068, 148069, 148070, 148071, 148072, 148074, 148075.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    CA and MN
  • Product Description
    Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Manufacturer Address
    Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441
  • Manufacturer Parent Company (2017)
    Integer Holdings Corporation
  • Source
    USFDA