Events

Recall of RX ACCULINK Carotid Stent System

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

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
    56973
  • Event Risk Class
    Class 2
  • Event Number
    Z-0338-2011
  • Event Initiated Date
    2010-09-10
  • Event Date Posted
    2010-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95084
  • 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
    Stent, carotid - Product Code NIM
  • Reason
    The recall was initiated because abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. if the affected device is used it may result in acute stent deployment difficulties and subsequent intervention.
  • Action
    Abbott Vascular sent an URGENT DEVICE RECALL letter dated September 10, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken. The Sales Representatives were to personally visit each account to deliver the recall letter and assist in identifying and returning any unused devices to Abbott Vascular. Also, Abbott Vascular Regulatory Compliance initiated contact with the Risk Management department at each account by phone to verify their mailing address and provide a courtesy copy of the recall letter. The consignees were instructed to work with their local account representative to review their inventory, complete the Recall Effectiveness Check and return identified products to Abbott Vascular. For questions regarding this recall call (951) 914-3324.

Device

RX ACCULINK Carotid Stent System
  • Model / Serial
    Lot Number: 0072061
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AL, CA, CT, DC, FL, GA, IA, IL, IN, MA, ME, MI, MN, MO, OH, OK PA, TX, VA, and WI
  • Product Description
    RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061 || The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • Manufacturer Address
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA