⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Abiomed, Inc.: Impella RP. Product Code: 0046-0011.

Medical DevicesSource: FDA (device) · Date: 2026-03-11

Read the official notice at FDA (device) →

Share on XFacebookRedditEmail

Get alerts for Abiomed

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Abiomed, Inc.
Product
Impella RP. Product Code: 0046-0011.
Reason / hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Classification
Class I
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Recall initiated
2026-01-27
Code info
Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.
Product quantity
179 units
Voluntary mandated
Voluntary: Firm initiated
City
Danvers
State
MA
Country
United States
Event id
98276
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.