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U.S. Department of Health and Human Services

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

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  Class 1 Device Recall Arrow International, Inc. Intraaortic balloon catheter see related information
Date Initiated by Firm February 02, 2009
Date Posted April 16, 2009
Recall Status1 Terminated 3 on July 06, 2010
Recall Number Z-1214-2009
Recall Event ID 51080
510(K)Number K040801  K021462  K000729  K010330  
Product Classification Intra-aortic balloon and control system - Product Code DSP
Product 7.5 Fr 30cc UltraFlex IAB,
IAB-06830-U, 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:  MF8039760 MF8039772 MF8040252 MF8040485 MF8040486 MF8040639 MF8050723 MF8050807 MF8050914 MF8061336 MF8061458 MF8061616 MF8061617 MF8071677 MF8071855 MF8082154 MF8082586 MF8092763 MF8093004 MF8103159 MF8103160 MF8103264 MF8103265 MF8103417 MF8124181 MF8124203 MF8124413 and MF8124414. 
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 2		 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 2,691 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.
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