Events

Recall of Device Recall Arrow International, Inc. Intraaortic balloon catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International, 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
    51080
  • Event Risk Class
    Class 1
  • Event Number
    Z-1219-2009
  • Event Initiated Date
    2009-02-02
  • Event Date Posted
    2009-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78486
  • 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
    A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on iabp model) rather than the appropriate 30, 40, or 50 cc volume.
  • Action
    An "Urgent Medical Device Recall" letter dated February 2, 2009 was issued to consignees via US Certified Mail to notify users of the problem. Users were instructed to check their inventory for the affected products, quarantine, and return the them to Arrow International, Inc. Customers were also instructed to follow the "Mitigation Directions" in circumstances where alternate Intra-Aortic Balloon (IAB) catheters/adaptors or other forms of therapy are not available (until receipt of available product). Canadian accounts were notified on February 9, 2009 by courier and International accounts notified on 6 February 2009 and 10 February 2009 via Registered Post/UPS. Direct questions to your local Sales Representative or the Arrow International Customer Service at 1-800-523-8446 (US) or 1-919-361-4062 (outside US). Press Release issued April 13, 2009 is posted to firm's webiste: http://www.arrowintl.com/iab_recall.asp.

Device

Device Recall Arrow International, Inc. Intraaortic balloon catheter
  • Model / Serial
    Lot/Serial Numbers:  MF6090326 MF6101289 MF7012817 MF7065399 MF7065882 MF7076380 MF7086744 MF7097061 MF7097113 MF7097319 MF7097474 MF7118038 MF7118039 MF7128469 MF7128554 MF7128555 MF7128556 MF8018842 MF8018976 MF8019000 MF8019100 MF8029244 MF8029295 MF8029296 MF8029509 MF8039793 MF8039794 MF8039988 MF8040431 MF8040432 MF8040433 MF8040445 MF8040601 MF8040602 MF8040603 MF8050760 MF8050761 MF8050986 MF8050987 MF8050988 MF8051091 MF8051092 MF8061324 MF8061325 MF8061456 MF8071619 MF8071627 MF8071628 MF8071789 MF8071849 MF8072043 MF8082319 MF8082320 MF8082321 MF8082322 MF8092737 MF8092833 MF8092870 MF8092871 MF8092872 MF8092873 MF8103163 MF8103164 MF8103165 MF8103166 MF8103167 MF8103168 MF8103568 MF8103569 and MF8103165.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.
  • Product Description
    8 FR 40CC Rediguard IAB, || IAB-S840C, Intra-aortic balloon catheter. || The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
  • Manufacturer
    Arrow International, Inc.

Manufacturer

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