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U.S. Department of Health and Human Services

Class 1 Device Recall Ultra 8 IAB

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  Class 1 Device Recall Ultra 8 IAB see related information
Date Initiated by Firm October 11, 2010
Date Posted December 23, 2010
Recall Status1 Terminated 3 on February 05, 2015
Recall Number Z-0791-2011
Recall Event ID 56965
510(K)Number K000729  K021462  
Product Classification Intra-Aortic Balloon and Control System - Product Code DSP
Product Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc.
Model: IAB-05840-U
Code Information Lot Numbers: KF0087855 KF0087856 KF0098040 KF0108374 MF0011189 MF0021654 MF0032271 MF0042406 MF0042501 MF0042786 MF0053023 MF0063353 MF0073903 MF0074071 MF7065606 MF7086741 MF7118151 MF7128507 MF8103280 MF8103571 MF8113919 MF8113951 MF8124345 MF9014575 MF9014817 MF9024965 MF9024993 MF9025112 MF9025209 MF9035509 MF9035685 MF9035955 MF9046057 MF9046247 MF9046501 MF9056746 MF9057069 MF9057070 MF9067275 MF9067738 MF9067740 MF9077954 MF9078048 MF9078052 MF9078348 MF9078349 MF9088685 MF9100025 MS0053114 MS9056684 MS9056857 MS9057154 MS9110263 MS9110269  
Recalling Firm/
Manufacturer		 Arrow International, Inc., Division of Teleflex Medical Inc.
9 Plymouth St
Everett MA 02149-1814
For Additional Information Contact SAME
617-389-6400
Manufacturer Reason
for Recall		 SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.
FDA Determined
Cause 2		 Device Design
Action Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.
Quantity in Commerce 13, 391 units
Distribution Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.
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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