Abiomed recalls Impella CP Smart Assist Set APAC (Product Code 0048-0047) due to potential interaction with Shockwave Coronary IVL Catheters during procedures. No current labeling addresses this risk, so Abiomed will update instructions.
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 a specific version of their Impella CP Smart Assist Set APAC device because it may interact dangerously with Shockwave Coronary IVL Catheters during heart procedures. The company says there's no current labeling for this risk and they'll update the instructions.
The device may interact with Shockwave Coronary IVL Catheters during coronary interventions, potentially causing complications. Currently, there's no labeling in the product instructions to address this interaction, so the risk exists but isn't actively causing injuries.
Healthcare professionals using the Impella CP Smart Assist Set APAC with Shockwave Coronary IVL Catheters during cardiac interventions. The risk is primarily for medical staff during procedures, not for end-users.
Check for the product code 0048-0047 on the Impella CP Smart Assist Set APAC. Serial numbers listed in the recall include many numbers starting with 388777 through 496772. Batch numbers 2023218526 through 2025524101 are also affected.
Review the product code, serial numbers, and batch numbers listed in the recall to confirm if your device is affected.
The recall states there's a potential interaction with Shockwave Coronary IVL Catheters during procedures, but no injuries have been reported. The company says there's no current labeling for this risk, so it's not actively causing harm.
Check if your device matches the product code 0048-0047 or the listed serial/batch numbers. If it's affected, you don't need to stop using it immediately, but Abiomed will update the instructions to address the interaction risk.
Yes, Abiomed will update the instructions (IFU) to include information about the potential device interaction with Shockwave Coronary IVL Catheters.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2960-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2960-2024 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.
