---
title: "Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. — FDA record Z-1030-2026 | Is It on Recall"
description: "Device packaged in incorrect outer box carton."
url: https://isitonrecall.com/recall/fda-device-z-1030-2026-impella-5-5-with-smartassist-s2-impella-5-5-with-smartassist-s2-set-au/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. — FDA record Z-1030-2026

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 Dec 4, 2025. 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 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
- **Reason**: Device packaged in incorrect outer box carton.
- **Classification**: Class II
- **Recalling firm**: Abiomed, Inc.
- **Quantity**: 6 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1030-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1030-2026%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 | Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27. \*\*\* UPDATE 05/02/2026\*\*\* Serial numbers added: 621448, 621449, 621450, and 621451; |

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

## Distribution

International distribution to the country of Australia and Taiwan.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Jan 14, 2026
- **Recall initiation date**: Dec 4, 2025
- **Center classification date**: Jan 8, 2026

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-1030-2026%22)

## Related records

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