FDA Device recall Z-2411-2020

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

FDA Device
Class I
terminated
Published 2020-07-08

On 2020-07-08 the FDA classified a Class I recall of Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E by Arrow International, citing 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 fail….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2411-2020
Classification	Class I
Status	terminated
Initiated	2020-05-20
Published	2020-07-08
Last updated	2026-09-13 11:55 UTC
Company	Arrow International
Distribution	n/a

Product

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

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.

Identifiers

code_info	Serial Number Ranges: AUTOCAT2 WAVE SPANISH IAP-0500E 150302W 150304W 150402W through 150403W 150408W… 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

code_info

Serial Number Ranges: AUTOCAT2 WAVE SPANISH IAP-0500E 150302W 150304W 150402W through 150403W 150408W…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2411-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.