Abiomed Impella RP devices recalled for possible sensor drift
The differential pressure sensor in certain Abiomed Impella RP heart pump devices may malfunction and provide inaccurate readings. This could affect the device's ability to monitor and respond appropriately during use. About 291 devices worldwide are affected.
From the FDA notice · Read the official notice ↗ · All Abiomed recalls
What to do
- Contact Abiomed immediately if you or a family member is using an Impella RP device
- Do not rely on sensor readings without verifying with your healthcare provider
- Work with your medical team to determine next steps for your specific situation
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Impella RP with SmartAssist. Product Code: 0046-0035.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 291 units
- Illnesses reported
- None reported
- Manufactured in
- 22 Cherry Hill Dr, N/A, Danvers, MA, United States
- Classification
- Class I
- Recall number
- Z-1469-2026
In the FDA's words
- Description
- Impella RP with SmartAssist. Product Code: 0046-0035. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. Product Code: 0046-0035. UDI-DI: 00813502011869. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland. Affected quantity: 291 units
- Hazard
- Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
3 products in this recall
Abiomed Impella RP heart pumps recalled for sensor drift risk
Abiomed is recalling three Impella RP heart pump models because the differential pressure (dP) sensor may malfunction and its readings may drift. The recall covers 4,966 units in total and was distributed in the US and several other countries. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Impella RP with SmartAssist. Product Code: 0046-0035. (this page)Z-1469-2026 · 291 units
- Impella RP Flex with SmartAssist. Product Code: 1000323.Z-1470-2026 · 4,496 units
- Impella RP. Product Code: 0046-0011.Z-1471-2026 · 179 units
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