Abiomed recalls specific Impella CP Smart Assist Set models in Canada due to potential interaction between Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. No immediate action required 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 certain Impella CP Smart Assist Sets sold in Canada because there's a potential interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during heart procedures. This could lead to device issues if used together without updated instructions.
The potential interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions could cause device malfunctions. Currently, there's no labeling to warn about this interaction, so healthcare providers might not be aware of the risk.
Healthcare professionals using the Impella CP Smart Assist Set in Canada are most at risk. Patients receiving these devices during coronary interventions may also be affected.
Check for the product code 0048-0044 or serial numbers listed in the recall notice. The batch numbers range from 2023212081 to 2025517284.
Review the product code (0048-0044) or serial numbers listed in the recall notice to confirm if your device is affected.
The recall is for potential device interaction during procedures, but no immediate action is required as labeling updates are pending.
No, the recall does not require stopping use immediately. Abiomed will update the instructions to address the interaction.
Check for product code 0048-0044 or serial numbers listed in the recall notice. The batch numbers range from 2023212081 to 2025517284.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2958-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2958-2024 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.
