||April 06, 2013
||Terminated on June 02, 2015
|Recall Event ID
System, balloon, intra-aortic and control -
||Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc;
Product Number: IAB-05840-LWS.
The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Arrow International Inc
2400 Bernville Road
|For Additional Information Contact
610-378-0131 Ext. 3474
|Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of
||Arrow International issued Urgent Medical Device Recall notification on 11/27/12. The letter identified the affected product and the reason for the recall. Accounts are requested to check their stock for the products included within the scope of this recall. Also, customers should cease use and distribution, and quarantine all affected product immediately. Contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization
Number. Customers are to complete and fax the Recall Acknowledgement & Stock Status Form to the number provided, and return the affected product. If customers have questions or need clarification regarding this issue, they should contact Arrow's Customer Service Department at 1-800-523-8446.
|Quantity in Commerce
||Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = DSP and Original Applicant = ARROW INTL., INC.