Abiomed recalls ImpellaCP SmartAssistSetAPAC models with potential device interaction during coronary interventions. No immediate action needed but updated instructions will address the risk.
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Abiomed is recalling specific ImpellaCP SmartAssistSetAPAC devices due to a potential interaction between the Shockwave Coronary IVL Catheter and left-sided Impella pumps during heart procedures. This could lead to complications if not properly managed, but the recall does not require immediate action.
The recall addresses a potential interaction between the Shockwave Coronary IVL Catheter and left-sided Impella pumps during heart procedures. This interaction could cause complications if not properly managed, but the risk is not immediate or severe.
Healthcare professionals using the ImpellaCP SmartAssistSetAPAC devices during coronary interventions are most at risk. Patients receiving these devices are not directly affected by this recall.
Check for the product code 1000302, serial numbers 392664-392669, or batch numbers 2023263121-2023269674 on the device packaging or label.
Review the product code, serial numbers, or batch numbers on the device packaging to confirm if it is part of the recall.
The recall addresses a potential interaction between devices during procedures, but it does not pose an immediate risk to users. Updated instructions will address the issue.
No immediate action is required. The recall does not ask users to stop using the device but will update instructions to address the interaction.
Check for product code 1000302, serial numbers 392664-392669, or batch numbers 2023263121-2023269674 on the device packaging or label.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2967-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2967-2024 from Abiomed. 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.
