Abiomed recalls Impella CP Pump 371 Set (Product Code 0048-0040) due to potential interaction with Shockwave Coronary IVL Catheter during 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 the Impella CP Pump 371 Set (Product Code 0048-0040) because it may interact dangerously with Shockwave Coronary IVL Catheters during heart procedures. This could lead to complications if used together without updated safety instructions.
The Impella pump and Shockwave Coronary IVL Catheter may interact during heart procedures, potentially causing complications. Currently, there are no updated safety instructions for this interaction, so the risk exists but is not immediate.
Healthcare professionals using the Impella CP Pump 371 Set during coronary interventions with Shockwave Coronary IVL Catheters. Patients receiving these procedures are at risk if the pumps interact with catheters.
Check for Product Code 0048-0040 on the Impella CP Pump 371 Set. Serial numbers include 370089, 370091, 370090, 370074, 370093, 401804, 401805, 401811, 401806.
Review the product code, serial numbers, and batch numbers listed in the recall notice to confirm if your device is affected.
The recall states there is a potential interaction but no immediate injury risk. Updated safety instructions will be provided by Abiomed.
No immediate action is required, but Abiomed will update the instructions to address the interaction risk.
Check the product code and serial numbers listed in the recall notice to confirm if your device is affected.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2957-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2957-2024 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.
