Impella RP with SmartAssist. Product Code: 0046-0035. recall (Abiomed, Inc.)
Medical deviceClass IOngoing
Summary: Abiomed, Inc. is recalling Impella RP with SmartAssist. Product Code: 0046-0035.. Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
What is being recalled
Impella RP with SmartAssist. Product Code: 0046-0035.
Why
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
How to tell if yours is affected
Product Code: 0046-0035. UDI-DI: 00813502011869.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1469-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | January 27, 2026 |
| Reported | March 11, 2026 |
| Company | Abiomed, Inc. |
| Company location | Danvers, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 291 units |
More recalls from Abiomed, Inc. · all medical device recalls · recalls from January 2026