Events

Recall of Device Recall TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardiac Assist, 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
    57414
  • Event Risk Class
    Class 2
  • Event Number
    Z-0889-2011
  • Event Initiated Date
    2010-12-02
  • Event Date Posted
    2011-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96093
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    Component (dilator of tandemheart transseptal cannula set-ef) does not meet specifications.
  • Action
    CardiacAssist, Inc. sent a Voluntary Recall letter dated November 12, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to examine inventory for the affected product and remove from inventory and identify it as a recalled product by applying the enclosed "CAUTION: DO NOT USE" sticker(s) and quarantine to prevent usage. Consignees were to complete the form included with the letter and fax a copy of the form to (412) 963-9739 to coordinate the return and replacement of any affected product. For questions regarding this recall call (412) 963-7770, ext. 271.

Device

Device Recall TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly
  • Model / Serial
    Part number 5140-6221 - Lot numbers 2010060684 & 2010071887
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
  • Product Description
    TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly || The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
  • Manufacturer
    Cardiac Assist, Inc

Manufacturer

Cardiac Assist, Inc
  • Manufacturer Address
    Cardiac Assist, Inc, 240 Alpha Dr, Pittsburgh PA 15238-2906
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA