Events

Recall of Device Recall DUOSTAT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Vascular-Cardiac Therapies dba Guidant Corporation.

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
    37019
  • Event Risk Class
    Class 2
  • Event Number
    Z-0391-2007
  • Event Initiated Date
    2006-12-05
  • Event Date Posted
    2007-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49774
  • 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
    Hemostatic Valve - Product Code DTL
  • Reason
    Specific lots of the .096' and .115' rotating hemostatic valves (rhv) and the duostat .096' rotating hemostatic valve (rhv) potentially have an incomplete seal in the packaging pouch.
  • Action
    On December 5, 2006, the firm began notifying all affected customers, affiliates and distributors of the recall via letter. The letter advises that the firm has voluntarily recalled specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) due to a potentially incomplete seal in the pouch. The letter advises Abbott Vascular will be replacing all returned product and that appropriate corrective actions will be implemented.

Device

Device Recall DUOSTAT
  • Model / Serial
    6090551
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Germany, Italy, Greece, New Zealand, Netherlands, France, Japan, Spain, and Bulgaria.
  • Product Description
    ACS DUOSTAT¿ Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23244
  • Manufacturer
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation

Manufacturer

Abbott Vascular-Cardiac Therapies dba Guidant Corporation
  • Manufacturer Address
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation, 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA