Abiomed recalls Impella CP Smart Assist Set (Product Code 1000402) due to potential device interaction with Shockwave Coronary IVL Catheters during heart procedures. No immediate action needed 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 CP Smart Assist Set (Product Code 1000402) because it may interact dangerously with Shockwave Coronary IVL Catheters during heart procedures. This could lead to complications if not properly managed by medical professionals.
The Impella pump and Shockwave Coronary IVL Catheter may interact during heart procedures, potentially causing complications. Currently, there is no labeling in the product instructions to warn about this interaction.
Medical professionals using the Impella CP Smart Assist Set during coronary interventions are most at risk. Patients using this device are not directly affected by the recall.
Check for Product Code 1000402 on the Impella CP Smart Assist Set. Serial numbers and batch numbers are listed in the recall notice for identification.
Review the product code, serial numbers, and batch numbers listed in the recall notice to confirm if your device is affected.
No, the recall is for medical professionals using the device during procedures. Patients are not directly affected by this recall.
The recall does not require stopping use; updated instructions will be provided to address the interaction risk.
Check for Product Code 1000402, serial numbers, and batch numbers listed in the recall notice.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2969-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2969-2024 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.
