---
title: "Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart... — FDA record Z-2319-2024 | Is It on Recall"
description: "Nine (9) Impella CP pumps failed inspection and were inadvertently released."
url: https://isitonrecall.com/recall/fda-device-z-2319-2024-impella-cp-with-smartassist-product-no-1000080-ref-0048-0003-left-heart-support-blood-pump/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump — FDA record Z-2319-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 31, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
- **Reason**: Nine (9) Impella CP pumps failed inspection and were inadvertently released.
- **Classification**: Class I
- **Recalling firm**: Abiomed, Inc.
- **Quantity**: 9 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2319-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2319-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Domestic only: FL, MA, OH TX.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Florida](https://isitonrecall.com/state/florida/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Jul 24, 2024
- **Recall initiation date**: May 31, 2024
- **Center classification date**: Jul 17, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2319-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Abiomed, Inc. records](https://isitonrecall.com/brand/abiomed-inc/)