Z-2413-2020Class I

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J

Name: Z-2413-2020 Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
Creator: Arrow International Inc
Published: 2020-05-20
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2020-05-20 / Terminated / root cause: design

FDA source

Arrow International Inc began a recall of Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J on 2020-05-20. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2413-2020
Classification: Class I
Status: Terminated
Initiated: 2020-05-20
Posted: 2020-06-26
Terminated: 2023-01-07
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
Product code: DSP System, Balloon, Intra-Aortic And Control
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.
Root cause tag: design
FDA 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 [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
Quantity in commerce: 2123 total
Distribution: Worldwide distribution.
Product codes and lots: Serial Number Ranges: AUTOCAT2 WAVE JAPANESE IAP-0500J 140866W through 140867W 150117W through 150118W 150120W 150201W 150305W 150307W through 150309W 150623W through 150624W 150713W through 150716W 151114W 151209W 151213W 151219W 160503W 160511W through 160515W 160517W 160635W through 160636W 160640W through 160641W 160731W through 160733W 171105W 171117W 171119W through 171120W 171201W 180120W 180301W

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2413-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2408-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2409-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2410-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2411-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2412-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2413-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2414-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2415-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2416-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2417-2020	Class I	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26

Product code DSP

K060309Class IIAutocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. / cleared 2006-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)