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U.S. Department of Health and Human Services

Class 1 Device Recall AutoCAT IABP Series

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  Class 1 Device Recall AutoCAT IABP Series see related information
Date Initiated by Firm May 20, 2020
Date Posted June 26, 2020
Recall Status1 Open3, Classified
Recall Number Z-2408-2020
Recall Event ID 85684
510(K)Number K060309  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
Code Information Serial number ranges: Arrow AutoCAT 2 Intra-Aortic Balloon Pump  AUTOCAT 2 IAP-0400 140868V  140901V through 140909V  140914V through 140920V  150102V  150106V through 150107V  150110V through 150113V  150115V through 150116V  150220V  150401V  150407V  150409V  150507V through 150513V  150601V through 150605V  150608V through 150611V  150625V  150702V through 150705V  150707V  150720V  150801V through 150802V  150821V  150824V  150827V through 150830V  150901V through 150906V  150908V through 150912V  150919V through 150923V  150925V through 150939V  151009V through 151013V  151015V through 151016V  151019V  151021V through 151027V  151029V  151102V through 151103V  151105V  151108V  151111V  151113V  151201V through 151208V  151210V through 151212V  151214V through 151218V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 151220V  160101V through 160103V  160105V through 160109V  160112V through 160118V  160120V  160122V  160126V  160201V through 160209V  160211V  160213V through 160214V  160216V through 160217V  160219V  160312V through 160314V  160316V through 160323V  160325V through 160327V  160331V  160401V through 160410V  160412V  160418V through 160422V  160519V  160525V  160529V through 160530V  160605V  160614V  160618V  160630V  160638V through 160639V  160645V  160703V  160718V  160720V  160726V  160728V through 160730V  170101V through 170110V  170401V through 170410V  170501V through 170520V  170601V through 170625V  170811V through 170830V  171021V through 171030V  171037V through 171046V  171106V through 171115V  180131V through 180150V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 180211V through 180230V  180411V through 180420V  180441V through 180450V  180521V through 180530V  180621V through 180630V  180711V through 180720V  180741V through 180750V  180811V through 180820V  181011V through 181040V  181111V through 181130V  190121V through 190130V  190141V through 190150V  190211V through 190220V  190411V through 190420V  190431V through 190440V  190531V through 190540V  190701V through 190712V  190737V through 190748V  190813V through 190824V  190837V through 190848V  190913V through 190924V  190937V through 190948V  191001V through 191012V  191025V through 191036V  191101V through 191112V  191137V through 191148V  200113V through 200136V  200314V through 200324V 
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact
610-378-0131
Manufacturer Reason
for Recall
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.
FDA Determined
Cause 2
Component design/selection
Action Urgent Medical Device Correction notification letters dated 5/20/20 were sent to customers. ACTIONS TO BE TAKEN BY FACILITIES (Immediate): Please immediately check your inventory of Arrow¿ AutoCAT¿2 and Arrow¿ AC3 Optimus¿ IABPs, whether stored or in use, and determine if you have an IABP with a model number listed above. Please see Appendix 1 for product codes and serial numbers. If an IABP in the scope of this Medical Device Correction displays a System Error 3 or High Baseline alarm, now or at any point in the future until the Long-Term Corrective Action detailed below occurs, immediately quarantine the device and contact Teleflex at 1-855-419-8507 or recalls@teleflex.com to receive support for inspection and servicing of the impacted device. We recommend against using an IABP for ground or air transport between medical facilities pending implementation of the Customer Action (Long Term). For IABP use during ground or air transport prior to implementation of the Customer Action (Long Term), it is recommended that the risks and benefits of using the IABP be assessed by the medical team treating the patient and that alternative circulatory support devices be considered. Customer Action (Subsequent): Teleflex will contact each impacted facility to schedule inspection and servicing of all IABP units that contain this internal component. This inspection and servicing will be performed onsite at facilities, for all IABP units. Facilities should adhere to the following instructions pending implementation of the Teleflex Long-Term Corrective Action described later in this letter: 1. Ensure that a backup IABP is available as instructed within the Operator Manual. If no such replacement IABP is immediately available, it is recommended that the risks and benefits of using the IABP be assessed by the medical team treating the patient and that alternative circulatory support devices be considered. 2. IABP units should be closely monitored during delivery of IAB
Quantity in Commerce 2123 total
Distribution Worldwide distribution.
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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