Quick Facts at a Glance
- Recall Date
- February 16, 2026
- Hazard Level
- HIGH
- Brand
- Abiomed
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Automated Impella Controller (AIC)
- Model numbers
- 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, 0042-0000-US, 0042-0010-EU, 0042-0010-UK, 0042-0040-CA, 0042-0040-EU +1 more
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 16, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
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: E-Mail
About This Product
The Impella Controller is part of a heart support system used in hospitals with the Impella 5.5 pump. It manages and displays purge and pump status.
Why This Is Dangerous
Delay in alarm display could hinder timely response to purge-system issues, potentially affecting patient safety.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals must pause use until the device is replaced or updated; potential workflow disruption and patient risk if alarms are not promptly displayed.
Practical Guidance
How to identify if yours is affected
- Check product code on the device (0042-0000-CA, -EU, -UK, -US, 0042-0010-EU, -0010-UK, 0042-0040-CA, -EU, -AU).
- Review serial numbers listed in the recall: IC2035, IC9416, IC1677, IC3049, IC3099, IC3102, IC4358, IC4329, IC5774, IC5757, IC6580, IC6581, IC2023, IC1910, IC2704, IC3325.
- Where to Find Info: FDA recall page and Abiomed official site for instructions.
- timelineExpectation: No formal timeline provided for refunds or replacements; remediation timelines typical range 4-8 weeks.
Where to find product info
FDA recall page and Abiomed support channels. Timeline and remedy details issued by Abiomed.
What timeline to expect
4-8 weeks for remediation actions typical in recalls.
If the manufacturer is unresponsive
- Document all contacts and responses with Abiomed.
- Escalate to hospital administration or patient safety office if the company is slow to respond.
How to prevent similar issues
- Verify device software is up to date before use.
- Ask clinicians to verify purge alarms and purge-system status monitoring.
- Keep a documented record of all device serials and recall notices.
Documentation advice
Keep copies of the recall notice, emails from Abiomed, and any correspondence with clinicians.
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Product Details
- Product Code: 0042-0000-CA; Impella Controller, Packaged, CA; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0000-EU; Impella Controller, Packaged, EU; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0000-UK; Impella Controller, Packaged, UK; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0000-US; Impella Controller, Packaged, US; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-0010-EU; Impella Optical Controller, Packaged, EU; Sold to hospitals internationally; Price: Unknown - Product Code: 0042-?
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Software versions affected: 8.2.2 through 8.5
- Hazard: delayed purge alarm display with first-gen Impella 5.5 pumps (0550-0008*)
- Distribution: Australia, Canada, France, Germany, Kuwait
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Safety Guide
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