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U.S. Department of Health and Human Services

Class 1 Device Recall Arrow AutoCAT 2 IABP

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  Class 1 Device Recall Arrow AutoCAT 2 IABP see related information
Date Initiated by Firm October 17, 2022
Date Posted December 15, 2022
Recall Status1 Open3, Classified
Recall Number Z-0444-2023
Recall Event ID 91021
510(K)Number K060309  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
Code Information UDI/DI (01) 3 0801902 09203 9, (01) 0 0801902 09203 8, All Lot/Serial Numbers
Recalling Firm/
Manufacturer		 ARROW INTERNATIONAL Inc.
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information Contact Customer Service
866-396-2111
Manufacturer Reason
for Recall		 There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
FDA Determined
Cause 2		 Pending
Action The firm issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 10/17/2022 by FedEx 2-day mail. To reduce the risk of short battery run time: .Plug IABP into an AC outlet during patient use, and when not in use. .Ensure the battery is fully charged prior to transporting patients, and a fully charged backup IABP device is available. .Replace the batteries when Battery Run Time is less than 90 minutes, there is visual damage to the battery, or Battery has been in service for 3 years. . Perform Battery Load Test at least every 12 months by qualified service personnel. If there is an issue with the battery load, immediately quarantine the device and contact Teleflex Customer Service to report the issue and receive service support for the affected IABP device. If a battery load test has not been performed in the past 12 months, perform battery load test prior to transporting patients with affected IABP devices. .If the IABP device battery fails while in use, immediately connect to an AC power source to continue therapy. .If a source of AC power is not available, transfer the patient to a fully charged back-up IABP device. .If pumping cannot be restored within 15 to 30 minutes, manually inflate and deflate the IAB several times per hour to reduce the risk of thrombus formation and consider removing the balloon. Facility Actions: Send a copy of this notification to all relevant personnel in your organization. Place a copy of this Notice with all affected products. Immediately check your inventory of Arrow AutoCAT2 and Arrow AC3 Optimus IABP, whether stored or in use. Return the Acknowledgement Form to Teleflex Customer Service. Hours of operation are 8am-7pm EST. Telephone: 1-866-396-2111, FAX: 1-855-419-8507 Email: Recalls@teleflex.com.
Quantity in Commerce 29 units
Distribution Worldwide
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSP and Original Applicant = ARROW INTL., INC.
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