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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-1215-2009
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 40cc UltraFlex IAB,
IAB-06840-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:  MF8029428 MF8029506 MF8029508 MF8030125 MF8030126 MF8039646 MF8039647 MF8039762 MF8039851 MF8040487 MF8040640 MF8050724 MF8061127 MF8061503 MF8071787 MF8072071 MF8082286 MF8082508 MF8093047 MF8103162 MF8103418 MF8103642 MF8113920 MF8114010 MF8124162 and MF8124162. 
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 7,325 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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