Abiomed recalls Impella 5.5 SmartAssist Set (Product Code 1000211) due to potential device interaction with Shockwave Coronary IVL Catheter during coronary interventions. Abiomed will update the IFU to include this interaction information.
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 the Impella 5.5 SmartAssist Set (Product Code 1000211) because there's a potential interaction between this pump and Shockwave Coronary IVL Catheters during heart procedures. This could lead to complications if used together without updated instructions.
The recall addresses a potential interaction between the Impella 5.5 SmartAssist Pump and Shockwave Coronary IVL Catheters during coronary interventions. Currently, there is no labeling in the product instructions (IFU) about this interaction, which could lead to complications if used together without updated instructions.
Healthcare professionals using the Impella 5.5 SmartAssist Set with Shockwave Coronary IVL Catheters during procedures. Patients using these devices are not directly affected by the recall.
The recalled product is the Impella 5.5 SmartAssist Set with Product Code 1000211. Serial numbers and batch numbers are listed in the recall notice. The product was sold with specific serial numbers and batch numbers from 2023191098 to 2024421135.
Review the product's serial numbers and batch numbers to confirm if it's affected. The recall includes specific serial numbers and batch numbers listed in the notice.
The recall addresses a potential interaction between the Impella 5.5 SmartAssist Pump and Shockwave Coronary IVL Catheters during procedures. There is no immediate risk of injury, but Abiomed will update the instructions to prevent complications.
No, the recall does not require immediate discontinuation. Abiomed will update the instructions to address the potential interaction, so users can continue using the product with updated guidance.
Check the product's serial numbers and batch numbers against the list provided in the recall notice. The affected products have specific serial numbers and batch numbers from 2023191098 to 2024421135.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2966-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2966-2024 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.
