Events

Recall of Ultra 8 IAB

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International, Inc., Division of Teleflex Medical 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
    56965
  • Event Risk Class
    Class 1
  • Event Number
    Z-0790-2011
  • Event Initiated Date
    2010-10-11
  • Event Date Posted
    2010-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95065
  • 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
    Intra-Aortic Balloon and Control System - Product Code DSP
  • Reason
    Superarrow flex iab catheter becomes stuck in the sheath, unable to move the iab catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.
  • Action
    Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.

Device

Ultra 8 IAB
  • Model / Serial
    Lot Numbers: KF0087756 MF0053016 MF0053017 MF0053018 MF0053019 MF0073778 MF0074136 MF0074137 MF5114292 MF7076257 MF7118004 MF7128505 MF8103263 MF8124064 MF8124178 MF8124307 MF8124408 MF9014573 MF9025207 MF9025208 MF9025213 MF9025226 MF9025227 MF9035382 MF9035448 MF9046246 MF9056839 MF9056840 MF9057065 MF9057066 MF9067735 MF9067736 MF9077955 MF9077968 MF9077969 MF9078203 MF9078343 MF9088501 MF9099356 MF9099357 MF9099358 MF9099359 MF9110054 MS9056710 MS9057152 MS9057153 MS9109664 MS9110295 MS9110368
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.
  • Product Description
    Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. || Model: IAB-05830-U
  • Manufacturer
    Arrow International, Inc., Division of Teleflex Medical Inc.

Manufacturer

Arrow International, Inc., Division of Teleflex Medical Inc.
  • Manufacturer Address
    Arrow International, Inc., Division of Teleflex Medical Inc., 9 Plymouth St, Everett MA 02149-1814
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA