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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 cathetersee related information
Date Initiated by FirmFebruary 02, 2009
Date PostedApril 16, 2009
Recall Status1 Terminated 3 on July 06, 2010
Recall NumberZ-1220-2009
Recall Event ID 51080
510(K)NumberK000729 K010330 K021462 K040801 
Product Classification Intra-aortic balloon and control system - Product Code DSP
Product9 FR 50CC Rediguard IAB, IAB-R950-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:  MF7076413 MF7086743 MF7097191 MF8092738 MR8039844 and MF8124297.  
Recalling Firm/
Manufacturer		 Arrow International, Inc.
9 Plymouth St
Everett MA 02149-1814
For Additional Information ContactMichael 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
ActionAn "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 Commerce267 units
DistributionWorldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DSP
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