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Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE… recallZ-2411-2020 · Arrow International Inc · initiated May 20, 2020

Class I Terminated All recalls posted in June 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Component design/selection

What the company is doing

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 [email protected] 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

Recall details

Recall number
Z-2411-2020
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
May 20, 2020
Posted by the FDA
Jun 26, 2020
Recalling firm
Arrow International Inc
Quantity
2123 total
Product code
DSP
FDA submissions
K060309
Distribution
Worldwide distribution.

Product description

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

11 devices cleared under K060309 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 85684).

Sources and updates

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