Quick Facts at a Glance
- Recall Date
- December 4, 2025
- Hazard Level
- HIGH
- Brand
- Abiomed
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Abiomed
- Product type
- Impella 5.5 with SmartAssist
- Model numbers
- Catalog Number: 1000482, Australian Configuration Code: 1000770, Serial No. 621454, Serial No. 621455
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 4, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Device packaged in incorrect outer box carton.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Impella 5.5 with SmartAssist is a cardiac assist device designed to support patients with severe heart conditions. It is commonly used in critical care settings to help maintain blood flow during high-risk procedures or recovery periods.
Why This Is Dangerous
The incorrect packaging could lead to confusion about the device's intended use or application, potentially risking patient safety. This is particularly problematic in high-stakes medical environments.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience and concern among patients and healthcare providers relying on the Impella 5.5 for critical care, emphasizing the importance of proper device handling and packaging.
Practical Guidance
How to identify if yours is affected
- Check the serial number on your Impella 5.5 device to see if it is 621454 or 621455.
- Verify the packaging to ensure it matches the expected outer carton specifications.
- Contact Abiomed or your healthcare provider for verification.
Where to find product info
The serial numbers and catalog numbers can typically be found on the device label or packaging.
What timeline to expect
Expect a timeline of 4-6 weeks for processing any refunds or replacements once the company is contacted.
If the manufacturer is unresponsive
- Document all communications with Abiomed and your healthcare provider.
- Follow up with a phone call if you do not receive a response within a week.
- Consider contacting the FDA if you experience continued delays.
How to prevent similar issues
- Always verify packaging and labeling when receiving medical devices.
- Stay informed about recalls in the medical device industry to ensure safety.
- Consult with healthcare providers about device options and safety before use.
Documentation advice
Keep records of the recall notice, communications with the company, and any receipts or documentation related to the device.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled products include the Impella 5.5 with SmartAssist, Catalog Number 1000482, and Australian Configuration Code 1000770. The affected units have serial numbers 621454 and 621455. They were distributed in Australia.
Key Facts
- Recall date: December 4, 2025
- Quantity recalled: 2 units
- Hazard level: High
- Affected serial numbers: 621454, 621455
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.