Abiomed recalls Impella 5.5 with SmartAssist S2 Set (EU) due to potential device interaction during coronary interventions. No current labeling addresses this risk, 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 certain Impella 5.5 with SmartAssist S2 Set devices sold in Europe. The recall is due to a potential interaction between this pump and Shockwave Coronary IVL Catheters during heart procedures. This could lead to complications if used together without updated instructions.
The Impella 5.5 pump and Shockwave Coronary IVL Catheter could interact during heart procedures, potentially causing complications. Currently, Abiomed does not have labeling that addresses this interaction, so users may not be aware of the risk.
Healthcare professionals using the Impella 5.5 with SmartAssist S2 Set in Europe are likely affected. Patients using these devices during coronary interventions may be at risk if the device interaction occurs.
Check for the product code 1000482 or serial numbers listed in the recall notice. The devices were sold in Europe with specific batch numbers from 2025451589 to 2025485532.
Look for the product code 1000482 or serial numbers listed in the recall notice to confirm if your device is affected.
The recall indicates a potential interaction risk during coronary interventions, but no specific injuries have been reported. Abiomed will update the instructions to address this.
The recall does not require immediate discontinuation; Abiomed will update the instructions to address the interaction risk.
Check for the product code 1000482 or serial numbers listed in the recall notice. The devices were sold in Europe with specific batch numbers from 2025451589 to 2025485532.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2971-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2971-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
