FDA Device recall Z-2410-2020

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

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, Product Code IAP-0500 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-2410-2020
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, Product Code IAP-0500

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 IAP-0500 140861W through 140865W 140910W through 140913W 150101W 1501… Serial Number Ranges: AUTOCAT2 WAVE IAP-0500 140861W through 140865W 140910W through 140913W 150101W 150103W through 150105W 150108W through 150109W 150114W 150119W 150202W through 150219W 150303W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 150306W 150310W 150404W through 150406W 150410W 150501W through 150506W 150515W 150606W through 150607W 150612W through 150622W 150701W 150706W 150708W through 150712W 150717W through 150719W 150803W through 150820W 150822W through 150823W 150825W 150913W through 150918W 150924W 150940W 151001W through 151008W 151017W through 151018W 151020W 151028W 151109W 151112W 151115W through 151120W 160104W 160110W through 160111W 160121W 160123W through 160125W 160127W through 160130W 160210W 160212W 160215W 160218W 160220W 160301W through 160304W 160307W through

code_info

Serial Number Ranges: AUTOCAT2 WAVE IAP-0500 140861W through 140865W 140910W through 140913W 150101W 1501…

Serial Number Ranges: AUTOCAT2 WAVE IAP-0500 140861W through 140865W 140910W through 140913W 150101W 150103W through 150105W 150108W through 150109W 150114W 150119W 150202W through 150219W 150303W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE IAP-0500 150306W 150310W 150404W through 150406W 150410W 150501W through 150506W 150515W 150606W through 150607W 150612W through 150622W 150701W 150706W 150708W through 150712W 150717W through 150719W 150803W through 150820W 150822W through 150823W 150825W 150913W through 150918W 150924W 150940W 151001W through 151008W 151017W through 151018W 151020W 151028W 151109W 151112W 151115W through 151120W 160104W 160110W through 160111W 160121W 160123W through 160125W 160127W through 160130W 160210W 160212W 160215W 160218W 160220W 160301W through 160304W 160307W through

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-2410-2020%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.