# FDA recall Z-0980-2024

> **Abiomed, Inc.** · Class I · device recall initiated 2023-12-27.

## Product

Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system.   (1) Product Code 005042 - Impella 2.5   (2) Product Code 005062 - Impella 5.0   (3) Product Code 005082- Impella LD   (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist   (8) Product Code 0048-0032 - Impella CP   (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist    ***Updated February 2024***   (10) 004413 - Impella 2.5 Set   (12) 0046-0026 - Impella 5.0 Pump Set ROW   (13) 0046-0037 - Impella 5.0 Pump Set APAC   (15) 004680-AU - 5.0 Pump Set AU   (16) 0048-0002 - Impella CP Pump Set, EU   (17) 0048-0002-BR - Impella CP Pump Set BR   (18) 0048-0004 - Impella CP Pump Set, Canada   (19) 0048-0014 - Impella CP Smart Assist Set, EU   (20) 0048-0024-JP - Impella CP Smart Assist Set, JP   (21) 0048-0044 - Impella CP Smart Assist Set, Canada   (22) 0048-0047 - Impella CP Smart Assist Set APAC   (23) 005040 - Impella 2.5 IMC Pump Set EU   (24) 005048-

## Reason for recall

IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

## Distribution

Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.

## Key facts

- **Recall number:** Z-0980-2024
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-27
- **Report date:** 2024-02-21

- **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-0980-2024

## Citation

> AI Analytics. FDA recall Z-0980-2024. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0980-2024. Source: US FDA. Licensed CC0.

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