Class 1 Device Recall Arrow International, Inc. Intraaortic balloon catheter

• Date Initiated by Firm: February 02, 2009
• Date Posted: April 16, 2009
• Recall Status: Terminated on July 06, 2010
• Recall Number: Z-1217-2009
• Recall Event ID: 51080
• 510(K)Number: K040801 K021462 K000729 K010330
• Product Classification: Intra-aortic balloon and control system - Product Code DSP
• Product: 8 Fr 40cc FIBEROPTIX IAB,; IAB-05840-LWS, 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.
• Code Information: Lot/Serial Numbers: MF7044497 MF7054982 MF7076013 MF7086515 MF7086964 MF7097339 MF7097388 MF7107535 MF7128358 MF7128419 MF7128466 MF8018705 MF8018706 MF8018707 MF8018725 MF8018726 MF8018729 MF8018846 MF8018847 MF8018848 MF8018924 MF8018925 MF8018998 MF8018999 MF8019101 MF8019102 MF8029111 MF8029166 MF8029167 MF8029168 MF8029256 MF8029257 MF8029258 MF8039704 MF8039705 MF8039706 MF8039707 MF8039709 MF8040286 MF8040326 MF8040543 MF8040641 MF8050720 MF8050721 MF8050722 MF8050806 MF8050912 MF8050913 MF8050982 MF8050995 MF8050996 MF8061126 MF8061177 MF8061185 MF8061405 MF8061406 MF8061457 MF8061501 MF8071783 MF8071784 MF8071785 MF8071786 MF8071853 MF8071854 MF8071864 MF8072072 MF8082151 MF8082395 MF8082396 MF8082397 MF8092764 MF8092786 MF8093003 MF8103157 MF8103158 MF8103640 MF8113837 MF8113838 MF8113839 MF8113840 MF8113949 MF8113950 MF8124161 MF8124179 MF8124202 MF8124179 MF8124202 MF8124309 MF8124340 MF8124410 and MF8124411.
• Recalling Firm/ Manufacturer: Arrow International, Inc.; 9 Plymouth St; Everett MA 02149-1814
• For Additional Information Contact: Michael A. Douglas; 617-389-6400
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process design
• 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.
• Quantity in Commerce: 6,922 units
• Distribution: Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DSP and Original Applicant = ARROW INTL., INC.