Abiomed recalls Impella 5.5 Set AU (Product Code 1000361) due to potential interaction with Shockwave Coronary IVL Catheters during heart procedures. No immediate action is required but updated instructions will be provided.
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 its Impella 5.5 Set AU medical device (Product Code 1000361) because it may interact dangerously with Shockwave Coronary IVL Catheters during heart procedures. This recall is being done to update the device instructions to prevent potential risks.
The Impella 5.5 pump and Shockwave Coronary IVL Catheter could interact during heart procedures, potentially causing complications. Currently, there is no labeling in the device instructions to warn about this interaction, which may lead to unintended risks.
Healthcare professionals using the Impella 5.5 Set AU device during coronary interventions are likely affected. Patients receiving these procedures are at risk if their devices interact with Shockwave Coronary IVL Catheters.
Check for Product Code 1000361 on the Impella 5.5 Set AU device. Serial numbers listed include 425570, 425332, and others. Batch numbers range from 2024286281 to 2024431720.
Look for Product Code 1000361, serial numbers starting with 425570 or 425332, and batch numbers between 2024286281 and 2024431720.
The recall states there is no current labeling warning about this interaction, but the hazard is being addressed by updating the device instructions. No immediate action is required.
The recall does not require stopping use; it only involves updating the device instructions to address the potential interaction.
Check the device for Product Code 1000361 and the listed serial/batch numbers. If you have the recalled model, Abiomed will update the instructions to include the interaction warning.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2968-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2968-2024 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.
