Reported Mar 11, 2026 · Ongoing
Impella RP. Product Code: 0046-0011.
Abiomed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 22 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
- Impella RP
- Product Code0046-0011
- Lot codes and dates
- Product Code0046-0011
- UDI-DI04260113630273. Distributed outside the US
- Amount recalled
- 179 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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