Abiomed recalls Impella 5.5 SmartAssist S2 Set (Product Code 1000459) due to potential 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 5.5 SmartAssist S2 Set (Product Code 1000459) because it may interact dangerously with Shockwave Coronary IVL Catheters during heart procedures. This could cause 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.
Healthcare professionals using the Impella 5.5 SmartAssist S2 Set during coronary interventions with Shockwave Coronary IVL Catheters. Patients receiving these procedures are at risk if the devices interact.
Check for Product Code 1000459 on the Impella 5.5 SmartAssist S2 Set. Serial numbers listed in the recall include 491248 through 509291. Batch numbers 2024434436 to 2025489208 are affected.
Verify your Impella 5.5 SmartAssist S2 Set has Product Code 1000459 and the listed serial numbers or batch numbers.
The recall is for potential interaction between the Impella pump and Shockwave Coronary IVL Catheters during procedures. No immediate harm has been reported, but updated safety instructions will be provided.
No immediate action is required. The recall states that updated instructions will be provided, so the device can continue to be used with proper guidance.
Check for Product Code 1000459 and the specific serial numbers or 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-2970-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2970-2024 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.
