Impella 5.5 SmartAssist S2 Recalled for Incorrect Outer Packaging

Agency Publication Date: January 8, 2026

Summary

Abiomed, Inc. is recalling two units of the Impella 5.5 with SmartAssist S2 and the Impella 5.5 with SmartAssist S2 Set (Australian configuration). These medical devices were placed inside the wrong outer packaging boxes. This error may lead to confusion regarding the specific device configuration during clinical use. No injuries or incidents have been reported related to this packaging error.

Risk

If a device is used from an incorrectly labeled box, medical staff might select the wrong equipment or misinterpret important details about the device's configuration during a procedure. This could lead to procedural delays or complications.

What You Should Do

This recall affects two units of the Impella 5.5 with SmartAssist S2 and Impella 5.5 with SmartAssist S2 Set (Australian Configuration) identified by serial numbers 621454 and 621455.
Identify the affected products by checking for Catalog Number 1000482, Australian Configuration Code 1000770, GTIN 00813502012828, and Lot 1000770 with an expiration date of June 30, 2027.
Stop using the recalled device immediately.
Contact Abiomed, Inc. or your distributor to arrange for a return, replacement, or correction of the affected units.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU

Variants: Australian Configuration

Model / REF:

1000482

1000770

Serial Numbers:

621454

621455

Lot Numbers:

1000770 (Exp 6/30/27)

GTIN:

00813502012828

Device packaged in incorrect outer box carton.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98086

Status: Active

Manufacturer: Abiomed, Inc.

Sold By: Hospitals; Surgical Centers; Medical Distributors

Manufactured In: United States

Units Affected: 2 units

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects two units of the Impella 5.5 with SmartAssist S2 and Impella 5.5 with SmartAssist S2 Set (Australian Configuration) identified by serial numbers 621454 and 621455.

Identify the affected products by checking for Catalog Number 1000482, Australian Configuration Code 1000770, GTIN 00813502012828, and Lot 1000770 with an expiration date of June 30, 2027.

Stop using the recalled device immediately.

Contact Abiomed, Inc. or your distributor to arrange for a return, replacement, or correction of the affected units.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.