Events

Recall of CapSureFix

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc. Cardiac Rhythm Managment.

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
    30369
  • Event Risk Class
    Class 3
  • Event Number
    Z-0207-05
  • Event Initiated Date
    2004-10-20
  • Event Date Posted
    2004-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35749
  • 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
    Tester, Pacemaker Electrode Function - Product Code DTA
  • Reason
    A specific lot of leads are labeled incorrectly. the leads are 45 cm in length and labeled as 52 cm lead length.
  • Action
    Letter of October 20, 2004, to direct customers, advised them to work with their respective Medtronic representatives to locate all leads and return them to Medtronic.

Device

CapSureFix
  • Model / Serial
    Model 5076 45 cm leads (PJN631011V and PJN631012V)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Leads were distributed to 21 consignees (hospitals/clinics) throughout the US.
  • Product Description
    Medtronic CapSureFix Novus Lead Model 5076.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Managment, 7000 Central Ave Ne, Fridley MN 55432
  • Source
    USFDA