Events

Recall of Eletrophysiology Catheter; BARD,Daig,BW CristaCath,Response,Supreme,Qwik Cable,BW Webster, Carto 3

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

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
    66712
  • Event Risk Class
    Class 2
  • Event Number
    Z-0340-2014
  • Event Initiated Date
    2013-10-18
  • Event Date Posted
    2013-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123045
  • 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
    Catheter, recording, electrode, reprocessed - Product Code NLH
  • Reason
    Stryker sustainability solutions is recalling the reprocessed diagnostic electrophysiology (ep) catheters cables due to a potential sterility breach in the package seal.
  • Action
    Stryker sent an Urgent Medical Device Removal Notification letter to affected customers. The letter informed customers of the affected product, problem identified and the actions to be taken. Customers are instructed to complete the "Recall Effectiveness Form" and fax to Moira Barton-Varty, Senior Director Regulatory Affairs at (480) 809-4957. Customers with any serious adverse events or product problems are instructed to call Stryker Sustainability Solutions at (888) 763-8803.

Device

Eletrophysiology Catheter; BARD,Daig,BW CristaCath,Response,Supreme,Qwik Cable,BW Webster, Carto 3
  • Model / Serial
    Lot/Serial numbers:  1529652 1535548 1538579 1538655 1562418 1562420 1568434 1568478 1596050 1258475 1596051 1535068 1535071 1535072 1559331 1363123 1406041 1531413 1533378 1533385 1535540 1596047 1596048 1471197 1539560 1539561 1541119 1596049 757895 1600879 1520424 1558826 1558827 1600880 1600881 1558103 1434511 1464987 1600882 1313231 1600883 1600884 1401578 1570964 1600670 1600671
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution: in the states of: Arizona, California, and Ohio.
  • Product Description
    Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. || Product Usage: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Note: These devices do not support or sustain life. Diagnostic EP Catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables interface an EP catheter with the appropriate external stimulation or recording equipment or serve as an extension cable between an EP catheter and equipment out of immediate reach. Reprocessed diagnostic electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Manufacturer Address
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA