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U.S. Department of Health and Human Services

Class 1 Device Recall AC3 Series IABP System

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  Class 1 Device Recall AC3 Series IABP System see related information
Date Initiated by Firm May 20, 2020
Date Posted June 26, 2020
Recall Status1 Open3, Classified
Recall Number Z-2416-2020
Recall Event ID 85684
510(K)Number K162820  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
Code Information Serial Number Ranges: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 150312F through 150313F  150315F  150318F  150321F  150324F through 150326F  161101F through 161110F  161112F through 161120F  161201F through 161210F  170101F through 170120F  170701F through 170710F  170801F through 170810F  170901F through 170920F  170931F through 170940F  171002F through 171010F  171031F through 171036F  171126F through 171130F  180101F through 180105F Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 180121F through 180125F  180201F through 180210F  180311F through 180330F  180401F through 180410F  180421F through 180425F  180431F through 180440F  180511F through 180520F  180601F through 180605F  180701F through 180710F  180801F through 180810F  180821F through 180825F  180922F through 180931F  181041F through 181050F  181101F through 181110F  181201F through 181210F  190101F through 190110F  190131F through 190135F  190201F through 190210F  190231F through 190250F  190301F through 190303F  190305F through 190320F  190331F through 190335F  190401F through 190410F  190421F through 190430F  190441F through 190450F  190501F through 190510F  190541F through 190550F  190601F through 190620F  190641F through 190645F  190713F through 190730F  190801F through 190812F  190826F through 190834F  190901F through 190912F  190925F through 190930F  191013F through 191018F  191037F through 191042F  191049F through 191054F  191113F through 191136F  191201F through 191212F  200101F through 200106F  200137F through 200148F  200201F through 200212F Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 200301F through 200306F  200325F through 200326F  200328F through 200339F  200341F through 200348F 
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 INTERNATIONAL, INC.
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