Impella RP. Product Code: 0046-0011. recall (Abiomed, Inc.)
Medical deviceClass IOngoing
Summary: Abiomed, Inc. is recalling Impella RP. Product Code: 0046-0011.. Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
What is being recalled
Impella RP. Product Code: 0046-0011.
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: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.
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-1471-2026 |
| 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 | 179 units |
More recalls from Abiomed, Inc. · all medical device recalls · recalls from January 2026