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U.S. Department of Health and Human Services

Class 1 Device Recall Arrow Ultra 8 IAB

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  Class 1 Device Recall Arrow 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-0969-2011
Recall Event ID 56965
510(K)Number K000729  K021462  
Product Classification intraaortic balloon system - Product Code DSP
Product Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters
Model: IAK-05845
Code Information Lot Numbers: KF0118523 MF8092597 MF8103402 MF8114055 MF9014548 MF9046091 MF9056823 MF9057130 MF9078053 MF9088776 MF9099410 MF9109907                                     
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 714
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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