Date Initiated by Firm | May 20, 2020 |
Date Posted | June 26, 2020 |
Recall Status1 |
Terminated 3 on January 07, 2023 |
Recall Number | Z-2409-2020 |
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 SPANISH, Product Code IAP-0400E |
Code Information |
Serial Number Ranges: 150301V 160119V 160429V through 160430V 160634V 160643V |
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 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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