FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
- Recall number
- Z-2414-2020
- Recalling firm
- Arrow International Inc
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
- Status
- Terminated
- Initiated
- 2020-05-20
- Posted
- 2020-06-26
- Terminated
- 2023-01-07
- Reason
- 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.
- Root cause
- 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
- 2123 total
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- Serial Number Ranges: 160714W through 160715W 160918W
- 510(k) numbers
- ["K060309"]
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28