Arrow recalls AC3 Optimus IABP models with serial numbers 150312F through 200348F due to vibration issues that could cause motor connector failures and pump shutdowns.
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.
Arrow is recalling certain AC3 Optimus Intra-Aortic Balloon Pumps that may stop working due to vibration-related motor connector issues. This could lead to sudden pump failure during medical use, which is serious for patients requiring this life-support device.
Vibration can cause motor connector wires inside the pump to fret, char, and discolor. This may trigger system alarms like 'System Error 3' or 'High Baseline' and could cause the pump to stop working suddenly during critical medical procedures.
Patients using the Arrow AC3 Optimus IABP for heart support are most at risk. Healthcare providers who use these devices in medical settings may also be affected.
Check the serial number on the pump's label. Affected models have serial numbers from 150312F through 200348F (e.g., 150312F, 150315F, 150318F, etc.).
Look for the serial number on the pump's label to confirm if it falls within the affected range (150312F through 200348F).
If you own this pump, contact your healthcare provider for guidance on next steps, as these devices are used in medical settings.
The pump's motor connector wires may fail due to vibration, causing system alarms and potential sudden shutdowns during medical use.
The pump may display 'System Error 3' or 'High Baseline' alarms and could stop functioning abruptly, which is dangerous for patients requiring continuous support.
Check the serial number on the pump's label. Affected models have serial numbers from 150312F through 200348F (e.g., 150312F, 150315F, 150318F, etc.).
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2416-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2416-2020 from Arrow. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
