Class 2 Device Recall Arrow

• Date Initiated by Firm: November 08, 2013
• Date Posted: March 10, 2015
• Recall Status: Terminated on March 16, 2015
• Recall Number: Z-1259-2015
• Recall Event ID: 70603
• 510(K)Number: K021462
• Product Classification: System, balloon, intra-aortic and control - Product Code DSP
• Product: Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), ; 8 Fr 40 cc; Model: IAB-05840-LWS
• Code Information: Lot Number: KF1111796 Exp. Date: 11/30/2013
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: 610-378-0131
• Manufacturer Reason for Recall: Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
• FDA Determined Cause: Process control
• Action: Arrow International Inc notified accounts by letter dated 11/8/13 describing the problem and requested users to immediately discontinue use and return product. A Recall Acknowledgement form was to be completed and returned.
• Quantity in Commerce: 166 units
• Distribution: Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.
• 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.