# FDA recall Z-1074-2024

> **Abiomed, Inc.** · Class II · 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 (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 100080 and 0048-0045 - Impella CP with SmartAssist  --  ***Added 2/20/24***  (10) 4413 and 004413 - Impella 2.5 Set (11) 5040 and 005040 - Impella 2.5 IMC Pump Set EU (12) 5060 and 005060 - Impella 5.0 IMC Pump Set EU (13) 5064 and 005064 - Impella 5.0 IMC Pump Set Canada (14) 1000115 - Impella CP Pump set, APAC (15) 1000211 - Impella 5.5 Smart Assist Set, JP (16) 1000302 - Impella CP with SmartAssist APAC (17) 1000361 - Impella 5.5 Set AU (18) 1000402 - Impella CP Smart Assist Set (19) 0046-0011 - Impel

## Reason for recall

New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.

## Distribution

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

## Key facts

- **Recall number:** Z-1074-2024
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class II
- **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-1074-2024

## Citation

> AI Analytics. FDA recall Z-1074-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1074-2024. Source: US FDA. Licensed CC0.

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