Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Impella 5.5 with SmartAssist Set Recalled by Abiomed, Inc. Due to A potential device interaction between the Shockwave Coronary...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abiomed, Inc. directly.
Affected Products
Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
Quantity: 2,916 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abiomed, Inc.
Abiomed, Inc. has 56 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report