Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Impella CP with SmartAssist Recalled by Abiomed, Inc. Due to Nine (9) Impella CP pumps failed inspection and...
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 CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Quantity: 9 units
Why Was This Recalled?
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Where Was This Sold?
This product was distributed to 4 states: FL, MA, OH, TX
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