Events

Recall of FindrWIRZ Guidewire System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SentreHeart 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
    75395
  • Event Risk Class
    Class 1
  • Event Number
    Z-0328-2017
  • Event Date Posted
    2016-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150382
  • 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
    A complaint was received on september 27th, 2016 at a medical center in germany for delamination and flaking of the ptfe lubricious coating on three findrwirz guidewire system .025 guidewires removed from their packaging hoops.
  • Action
    SentreHeart sent an Urgent Medical Device Voluntary Recall letter dated September 29, 2016, to all affected customers by traceable delivery method. Letters explained the issue and requested that any devices from the two affected lots be returned to SentreHEART immediately. Customers were asked to complete and return the enclosed response form as soon as possible via fax at 650-354-1204 or email to customerservice@sentreheart.com. Customers with questions were instructed to call 1-855-256-7330. For questions regarding this recall call 650-241-6008.

Device

FindrWIRZ Guidewire System
  • Model / Serial
    Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany
  • Product Description
    FindrWIRZ Guidewire System Catalog# 40-05 || Cardiology: || The system is intended for use in the cardiovascular system for || introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
  • Manufacturer
    SentreHeart Inc

Manufacturer

SentreHeart Inc
  • Manufacturer Address
    SentreHeart Inc, 300 Saginaw Dr, Redwood City CA 94063-4743
  • Manufacturer Parent Company (2017)
    SentreHEART Inc.
  • Source
    USFDA