FDA recall, , High risk
Impella RP
The Impella RP devices have a sensor that may malfunction, causing sensor values to drift.
Summary by Recall Canary from the FDA notice
What happened
Abiomed, Inc., of Danvers, Massachusetts, recalled Impella RP Flex with SmartAssist, Impella RP, and Impella RP with SmartAssist devices because the differential pressure (dP) sensor may malfunction, causing sensor values to drift. The recall began January 27, 2026, and was added to the FDA's Enforcement Report on February 27, 2026.
Distribution was worldwide, including the US Nationwide and countries such as Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, and Switzerland.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Match the UDI-DI and product code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Impella RP Flex with SmartAssist.
- UDI-DI
- 00813502012811
- Product code
- 1000323.
Impella RP.
- UDI-DI
- 04260113630273
- Product code
- 0046-0011.
Impella RP with SmartAssist.
- UDI-DI
- 00813502011869
- Product code
- 0046-0035.
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
- Company
- Abiomed, Inc.Danvers, Massachusetts
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98276
- Recall numbers
- Z-1469-2026 to Z-1471-2026
All recalls from Abiomed, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
