Events

Recall of Device Recall PREFACE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosense Webster, 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
    36988
  • Event Risk Class
    Class 2
  • Event Number
    Z-0539-2007
  • Event Initiated Date
    2006-11-17
  • Event Date Posted
    2007-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49715
  • 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
    intravascular guiding sheath - Product Code DYB
  • Reason
    Biosense webster, inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the preface sheath during use in the left atrium.
  • Action
    Initially a Medical Device Correction Advisory letter was mailed on November 20, 2006 to all domestic and international consignees recommending to customers that the Preface Sheath was not to be used with the NaviStar ThermoCool Catheter or any 8 French or larger catheter. On December 9, 2006, a Recall Customer letter and Certification form were sent out to all customers and Johnson & Johnson affiliates who had purchased the product in the past three years. For customers in the US, two letters and forms were sent out -one addressed to the EP/Cardiology Lab and the second to the Risk Management Office. For the US, customers will return product directly to Biosense Webster afler receiving a return authorization number. Returned product will be segregated and labeled as quarantined product. Returned product will be used as necessary for the root cause investigation. Any product not used at the conclusion of the investigation will be destroyed. For international customers, product will be returned to the Biosense Webster warehouse in Roden, Netherlands or to the Biosense Webster US warehouse (depending on order placement) if export issues don''t present a problem. If product cannot be easily returned to Biosense Webster, the customers will be instructed to destroy the product and provide notification that the destruction was performed.

Device

Device Recall PREFACE
  • Model / Serial
    Lot numbers: 13073872,  13078568,  13082798,  13084602,  13088356,  13096358,  40206984, 40604122, 40804442,  50205751, 50306355,  50403002,  50405034,  51104857,  A0105904,  A0106063,  A0206419, A1102924, X0105497,  X0205439,  X0305391,  X0306127, X0306956,  X0405043,  X0505118,  X0704423, X0802743, X0805081 & X0905452
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.
  • Product Description
    Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301805M
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Manufacturer Address
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA