FDA Device recall Z-2416-2020

Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700

FDA Device
Class I
terminated
Published 2020-07-08

On 2020-07-08 the FDA classified a Class I recall of Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700 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-2416-2020
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 AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700

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 AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 150312F through 15… Serial Number Ranges: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 150312F through 150313F 150315F 150318F 150321F 150324F through 150326F 161101F through 161110F 161112F through 161120F 161201F through 161210F 170101F through 170120F 170701F through 170710F 170801F through 170810F 170901F through 170920F 170931F through 170940F 171002F through 171010F 171031F through 171036F 171126F through 171130F 180101F through 180105F Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 180121F through 180125F 180201F through 180210F 180311F through 180330F 180401F through 180410F 180421F through 180425F 180431F through 180440F 180511F through 180520F 180601F through 180605F 180701F through 180710F 180801F through 180810F 180821F through 180825F 180922F through 180931F 181041F through 181050F 181101F through 181110F 1812

code_info

Serial Number Ranges: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 150312F through 15…

Serial Number Ranges: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 150312F through 150313F 150315F 150318F 150321F 150324F through 150326F 161101F through 161110F 161112F through 161120F 161201F through 161210F 170101F through 170120F 170701F through 170710F 170801F through 170810F 170901F through 170920F 170931F through 170940F 171002F through 171010F 171031F through 171036F 171126F through 171130F 180101F through 180105F Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA IAP-0700 180121F through 180125F 180201F through 180210F 180311F through 180330F 180401F through 180410F 180421F through 180425F 180431F through 180440F 180511F through 180520F 180601F through 180605F 180701F through 180710F 180801F through 180810F 180821F through 180825F 180922F through 180931F 181041F through 181050F 181101F through 181110F 1812

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-2416-2020%22

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