Abiomed recalls Impella 5.5 with SmartAssist Set due to potential interaction with Shockwave Coronary IVL Catheter during procedures. No immediate action needed per current labeling, but updated instructions will address the risk.
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 Impella 5.5 with SmartAssist Set because it may interact dangerously with Shockwave Coronary IVL Catheters during heart procedures. This risk exists because current instructions don't cover the interaction, though the company plans to update the manual.
The Impella pump and Shockwave Coronary IVL Catheter could interact during heart procedures, potentially causing complications. This interaction risk is not covered in current device instructions, so healthcare providers might not be aware of the danger.
Healthcare professionals using the Impella 5.5 with SmartAssist Set for cardiac procedures are most at risk if they interact with Shockwave Coronary IVL Catheters. Patients using these devices are not directly affected by the recall.
Check for the product code 0550-0004 on the Impella 5.5 with SmartAssist Set. Serial numbers include 439898, 437211A, 437204A, and other numbers listed in the recall notice.
Review the product code, serial numbers, and batch numbers listed in the recall notice to confirm if your device is affected.
No, this recall affects healthcare professionals using the device during procedures, not patients directly.
The recall does not require immediate discontinuation; updated instructions will 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-2962-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2962-2024 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.
