Events

Recall of Device Recall ChoICE PT Extra Support PTCA Guide Wire

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
    25502
  • Event Risk Class
    Class 3
  • Event Number
    Z-0590-03
  • Event Initiated Date
    2002-08-22
  • Event Date Posted
    2003-02-27
  • 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=25933
  • 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
    Product labeled as scimed choice pt extra suport ptca guide wire 300 cm were actually scimed pt graphix intermediate ptca guide wire 300 cm.
  • Action
    Recall letters with response forms were sent to hosptials via FED EX on 8/22/02. Product was to be returned to Boston Scientific in Quincy, MA.

Device

Device Recall ChoICE PT Extra Support PTCA Guide Wire
  • Model / Serial
    Individual Devices in Pouches with Catalog No. 12155-01, UPN H74912155011, Lot Number 4773987, exp. date 2004-5. These pouches were packaged in two lots of five-pack boxes with the following codes: Catalog 12155-01, lot 4791304 Catalog 12155-01, lot 4798294
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts.
  • Product Description
    Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length
  • Manufacturer
    Symbiosis Corp.

Manufacturer

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