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Class 1 Device Recall Arrow International, Inc. Intraaortic balloon catheter |
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Date Initiated by Firm |
February 02, 2009 |
Date Posted |
April 16, 2009 |
Recall Status1 |
Terminated 3 on July 06, 2010 |
Recall Number |
Z-1218-2009 |
Recall Event ID |
51080 |
510(K)Number |
K040801 K021462 K000729 K010330
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Product Classification |
Intra-aortic balloon and control system - Product Code DSP
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Product |
7 FR 30CC Rediguard IAB, IAB-S730C, 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.
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Code Information |
Lot/Serial Numbers: MF7012650 MF7065398 MF7076011 MF7086585 MF7086981 MF7097060 MF7097473 MF7107623 MF7117871 MF7128553 MF8018756 MF8018814 MF8019001 MF8019036 MF8029114 MF8029190 MF8039773 MF8039989 MF8040133 MF8050762 MF8050763 MF8050985 MF8051093 MF8061455 MF8071620 MF8082323 MF8082324 MF8082325 MF8092832 MF8103260 MF8124197 MF8124198 MF8124198 and MF8124282. |
Recalling Firm/ Manufacturer |
Arrow International, Inc. 9 Plymouth St Everett MA 02149-1814
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For Additional Information Contact |
Michael A. Douglas 617-389-6400
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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.
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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 |
4,411 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
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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.
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510(K) Database |
510(K)s with Product Code = DSP and Original Applicant = ARROW INTL., INC.
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