Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1471-2026 — Impella RP. Product Code: 0046-0011.

U.S. FDA — Device Enforcement · United States · 2026-01-27 · Class I

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1471-2026
Date of alert
2026-01-27
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Abiomed, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04260113630273
Reported risk: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.