# FDA recall Z-1471-2026

> **Abiomed, Inc.** · Class I · device recall initiated 2026-01-27.

## Product

Impella RP. Product Code: 0046-0011.

## Reason for recall

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

## Distribution

Worldwide distribution - US Nationwide  and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.

## Key facts

- **Recall number:** Z-1471-2026
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-27
- **Report date:** 2026-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danvers, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1471-2026

## Citation

> AI Analytics. FDA recall Z-1471-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1471-2026. Source: US FDA. Licensed CC0.

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