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 RP with SmartAssist. Product Code: 0046-0035. Recalled by Abiomed, Inc. Due to Differential pressure (dP) sensor in Impella RP devices...
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 RP with SmartAssist. Product Code: 0046-0035.
Quantity: 291 units
Why Was This Recalled?
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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