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U.S. Department of Health and Human Services

Class 1 Device Recall Arrow AutoCAT2

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  Class 1 Device Recall Arrow AutoCAT2 see related information
Date Initiated by Firm May 20, 2020
Date Posted June 26, 2020
Recall Status1 Terminated 3 on January 07, 2023
Recall Number Z-2411-2020
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 AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
Code Information Serial Number Ranges:  AUTOCAT2 WAVE SPANISH IAP-0500E 150302W  150304W  150402W through 150403W  150408W  150514W  150826W  151014W  151107W  151110W  160425W through 160427W  160508W through 160510W  160518W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH IAP-0500E 160631W  160637W  160642W  160644W  160705W  160919W  170204W through 170206W  170221W  170308W  170328W  170928W  171116W  180333W  180840W  180939W  181054W  181056W through 181060W  190229W  190512W  190514W  190519W  190631W through 190633W 
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 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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