Events

Recall of Device Recall Enpath Steerable Sheath

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
    33338
  • Event Risk Class
    Class 2
  • Event Number
    Z-1573-05
  • Event Initiated Date
    2005-08-31
  • Event Date Posted
    2005-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41714
  • 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
    Introducer, Catheter - Product Code DYB
  • Reason
    Enpath has become aware that some of the enpath medical 8 fr steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole.
  • Action
    Clinical locations were sent an Urgent Medical Device Recall letter dated 09/02/05 from Enpath Medical, Inc. The letter states the issue, affected lots to be segregated and to discontinue use of. A Bard Electrophysiology Territory Manager will retrieve affected product.

Device

Device Recall Enpath Steerable Sheath
  • Model / Serial
    W34968 and W35440
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MA
  • Product Description
    Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minneapolis, MN 55447, USA. The Enpath Deflectable Catheter is a felexible tipped percutaneous catheter designed for gaining access to the peripheral and coronary systems. The device features adjustable tip geometry through use of a sliding mechanism with locking feature to deflect the catheter. There are two versions of the tool: one with a luer fitting for Tuohy-Borst valve connection, the other with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate deflectable catheter passage.
  • Manufacturer
    Enpath Medical, Inc.

Manufacturer

Enpath Medical, Inc.
  • Manufacturer Address
    Enpath Medical, Inc., 15301 Highway 55, Plymouth MN 55447-1418
  • Source
    USFDA