Events

Recall of Device Recall enpath Myopore Bipolar 54 cm Epicardial Lead Sutureless Myocardial Pacing Lead

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
    56324
  • Event Risk Class
    Class 2
  • Event Number
    Z-0287-2011
  • Event Initiated Date
    2010-05-13
  • Event Date Posted
    2010-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93235
  • 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
    Permanent pacemaker electrode - Product Code DTB
  • Reason
    The myopore bipolar epicardial leads packaging is labeled as unipolar leads. the lead body itself is correctly labeled as bipolar. this could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode.
  • Action
    Greatbatch Medical issued an Urgent Medical Device Recall letter dated May 13, 2010 to their distributor. The letter described the problem and product involved, and gave the action required which included: 1) immediately discontinue distribution of the units and return any unused units to Greatbatch Medical. 2) Reconcile medical recordsbetween BSC and Greatbatch Medical to confirm implant data 3) Confirm pulse generator type (bipoloar, unipolar, or unknown) used with each serial number listed Greatbatch will work with customers to contact physicians as necessary regarding patient monitoring. Greatbatch Medical can be contacted at 763-951-8312.

Device

Device Recall enpath Myopore Bipolar 54 cm Epicardial Lead Sutureless Myocardial Pacing Lead
  • Model / Serial
    serial numbers: 123070, 123072, 123073, 123075 thru 123092, 123094, 123095, 123097 thru 123104, 123431, 123432, 123433.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: to USA and Europe, through distributor in MN.
  • Product Description
    enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by 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