Abiomed recalls Japan-sold Impella CP Pump Sets (Product Code 0048-0034-JP) due to potential interaction with Shockwave Coronary IVL Catheters during heart procedures. No immediate action needed as labeling update is pending.
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 Impella CP Pump Sets sold in Japan because they could interact dangerously with Shockwave Coronary IVL Catheters during heart procedures. This risk is being addressed by updating the product instructions, but no immediate action is required for users.
The Impella CP Pump Set could interact with Shockwave Coronary IVL Catheters during heart procedures, potentially causing device malfunction. This interaction is not currently covered in the product instructions, which will be updated to address the issue.
Users of the recalled Impella CP Pump Sets in Japan are most at risk during coronary interventions involving Shockwave Coronary IVL Catheters. Healthcare professionals using these devices are the primary affected group.
Check for Product Code 0048-0034-JP on the Impella CP Pump Set sold in Japan. Serial numbers 324303, 323153, 328083, and 328085 are also associated with this recall.
Look for Product Code 0048-0034-JP or the listed serial numbers on the Impella CP Pump Set.
No immediate risk exists as the product instructions will be updated to address the interaction. Users do not need to stop using the device.
Check the product label for the Product Code 0048-0034-JP or the listed serial numbers. No action is needed beyond verifying the product.
The recall involves updating the product instructions, not repairs or replacements. No action is required from users.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2956-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2956-2024 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.
