Date Initiated by Firm | May 20, 2020 |
Date Posted | June 26, 2020 |
Recall Status1 |
Terminated 3 on January 07, 2023 |
Recall Number | Z-2416-2020 |
Recall Event ID |
85684 |
510(K)Number | K162820 |
Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
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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
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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 AutoCAT2 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 |
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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.
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510(K) Database | 510(K)s with Product Code = DSP
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