FDA Device recall Z-2408-2020

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400

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 AUTOCAT 2, Product Code IAP-0400 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-2408-2020
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 AUTOCAT 2, Product Code IAP-0400

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: Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 140868V 140901V through 14090… Serial number ranges: Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 140868V 140901V through 140909V 140914V through 140920V 150102V 150106V through 150107V 150110V through 150113V 150115V through 150116V 150220V 150401V 150407V 150409V 150507V through 150513V 150601V through 150605V 150608V through 150611V 150625V 150702V through 150705V 150707V 150720V 150801V through 150802V 150821V 150824V 150827V through 150830V 150901V through 150906V 150908V through 150912V 150919V through 150923V 150925V through 150939V 151009V through 151013V 151015V through 151016V 151019V 151021V through 151027V 151029V 151102V through 151103V 151105V 151108V 151111V 151113V 151201V through 151208V 151210V through 151212V 151214V through 151218V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 151220V 160101V through 160103V

code_info

Serial number ranges: Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 140868V 140901V through 14090…

Serial number ranges: Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 140868V 140901V through 140909V 140914V through 140920V 150102V 150106V through 150107V 150110V through 150113V 150115V through 150116V 150220V 150401V 150407V 150409V 150507V through 150513V 150601V through 150605V 150608V through 150611V 150625V 150702V through 150705V 150707V 150720V 150801V through 150802V 150821V 150824V 150827V through 150830V 150901V through 150906V 150908V through 150912V 150919V through 150923V 150925V through 150939V 151009V through 151013V 151015V through 151016V 151019V 151021V through 151027V 151029V 151102V through 151103V 151105V 151108V 151111V 151113V 151201V through 151208V 151210V through 151212V 151214V through 151218V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 151220V 160101V through 160103V

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-2408-2020%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.