Events

Recall of Device Recall Boston Scientific

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Symbiosis Corp..

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
    25704
  • Event Risk Class
    Class 3
  • Event Number
    Z-0666-03
  • Event Initiated Date
    2002-11-27
  • Event Date Posted
    2003-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26301
  • 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
    Wire, Guide, Catheter - Product Code DQX
  • Reason
    The 180 cm guidewire is mislabeled as 260 cm and the 260 cm guidewire is mislabeled as 180 cm.
  • Action
    A Recall Notification Letter was send to hospitals via Federal Express Overnight Delivery, on 11/27/2002 to the attention of the Risk Manager and the Cath Lab Manager. In addition a response form was included. Recalled units are to be returned to the Boston Scientific Distribution Center located at 500 Commander Shea Blvd., Quincy, MA 02171.

Device

Device Recall Boston Scientific
  • Model / Serial
    Pouch codes for the 180 cm length wuidewires are:  Catalog No. 46-591, UPN M001465910 Lot Number Use Before Date 4959940 2005-08 4959941 '' 4969651 '' 4969654 '' 4969655 '' 4969656 ''  The pouch codes for the 260 cm length guidewires are: Catalog No. 46-5912, UPN M001465920 Lot Number Use Before Date 4959945 2005-08 4959946 '' 4959944 '' 4959943 ''
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 118 hospitals nationwide.
  • Product Description
    Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.
  • Manufacturer
    Symbiosis Corp.

Manufacturer

Symbiosis Corp.
  • Manufacturer Address
    Symbiosis Corp., 8600 NW 41th Street, Miami FL 33166
  • Source
    USFDA