Arrow recalls certain AC3 Optimus IABP models due to vibration issues that could cause pump alarms or sudden shutdowns. Affected units have specific serial number ranges.
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 specific models of AC3 Optimus Intra-Aortic Balloon Pumps because a component may fail due to vibration, leading to pump alarms or sudden stoppage. This could be dangerous for patients using the device.
Vibration can cause the 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 lead to the pump stopping unexpectedly.
Patients using the recalled AC3 Optimus IABP models are most at risk. Healthcare providers who use these devices in medical settings may also be affected.
Check for serial numbers starting with '170831F' through '200311F' in the specified ranges. The product is sold under the Arrow AC3 Optimus IABP NA/AJLA model with product code IAP-0701.
Look for the serial number on the pump's label, which should match the ranges listed in the recall notice.
Reach out to Arrow International directly for specific instructions on whether the device needs repair or replacement.
The pump's motor connector wires may fail due to vibration, causing alarms or sudden stoppage of the device.
Check the serial number against the recall ranges and contact Arrow for guidance on next steps.
Yes, the pump may stop working unexpectedly or show alarms, which could be dangerous for patients using it.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2417-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2417-2020 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.
