Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH… recallZ-2409-2020 · Arrow International Inc · initiated May 20, 2020

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-2409-2020

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 SPANISH, Product Code IAP-0400E

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.

• ARROW IPN000320

  Teleflex Incorporated · System, balloon, intra-aortic and control
  2 deaths383 reports
• ARROW IPN000302

  Teleflex Incorporated · System, balloon, intra-aortic and control
  54 reports
• ARROW IPN000325

  Teleflex Incorporated · System, balloon, intra-aortic and control
  44 reports
• ARROW IPN000324

  Teleflex Incorporated · System, balloon, intra-aortic and control
  14 reports
• ARROW IPN000329

  Teleflex Incorporated · System, balloon, intra-aortic and control
  8 reports
• ARROW IPN000308

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 report
• ARROW IPN000312

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 report
• ARROW IPN000333

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 report
• ARROW IPN000334

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 report
• ARROW IPN000323

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 report
• ARROW IPN000328

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 report

Other products in the same recall event

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

• Z-2408-2020 · Terminated
  Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
• Z-2410-2020 · Terminated
  Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
• Z-2411-2020 · Terminated
  Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
• Z-2412-2020 · Terminated
  Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
• Z-2413-2020 · Terminated
  Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
• Z-2414-2020 · Terminated
  Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
• Z-2415-2020 · Terminated
  Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535