Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Impella 5.5 with SmartAssist¿ S2 Recalled by Abiomed, Inc. Due to Device packaged in incorrect outer box carton.
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¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Quantity: 2 units
Why Was This Recalled?
Device packaged in incorrect outer box carton.
Where Was This Sold?
International distribution to the country of Australia.
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