Events

Recall of Device Recall Bard

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
    35827
  • Event Risk Class
    Class 2
  • Event Number
    Z-0118-2007
  • Event Initiated Date
    2006-06-27
  • Event Date Posted
    2006-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46968
  • 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
    guide catheter delivery sheath - Product Code DQY
  • Reason
    Enpath has become aware that some of the enpath medical 8f & 9f steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.
  • Action
    Enpath''s three Distributors were notified via letter or telephone on June 27th, 29th and July 6th with a description of the problem and further distribution or use of any remaining product should cease immediately. Instructed to notify their customers about the product and forward to Enpath for evaluation.

Device

Device Recall Bard
  • Model / Serial
    Model # 8F: Enpath Part Number 10775-003, BARD Part Number XD10775003 (Distributed in US and Internationally). 8F Lots #s W34968 (80 units), W35440 (35 units), W35522 (40 units), W35705 (17 units, sent as SAMPLES, labeled NOT FOR HUMAN USE), W35719 (320 units), W35952 (79 units), W37292 (300 units), W37567 (116 units), W38340 (298 units), W38341 (87 units), W38342 (87 units), W38974 (99 units), W38975 (100 units), W39174 (100 units), W40410 (100 units), W40479 (87 units), W40480 (85 units), W40481 (100 units), W40483 (87 units).  Model # 9F: Enpath Part Number 10775-004 (9F), BARD Part Number XD10775004, (Distributed Internationally (EU) only), 9F lot #s; W36392 (3 units), W36623 (5 units), W36884 (2 units), W36974 (8 units).
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, MA
  • Product Description
    Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division.
  • Manufacturer
    Enpath Medical, Inc.

Manufacturer

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