Quick Facts at a Glance
- Recall Date
- August 20, 2025
- Hazard Level
- HIGH
- Brand
- Abiomed
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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-US, 0042-0000-US-L, 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, 0042-0000-UK-L
- Sold at
- Unknown
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 20, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
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
Impella Controller is used with a heart assist pump for cardiac support. The AIC manages pump function.
Why This Is Dangerous
A Pump Driver Circuit Assembly that does not meet specifications can cause the pump to underperform or stop, triggering alarms.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
High risk to patients requiring precise pump function during cardiac support; impact includes potential treatment delay and hospital readjustments.
Practical Guidance
How to identify if yours is affected
- Match the model codes to the recall list.
- Inspect label on device packaging and documentation.
- Check with hospital biosafety or biomedical engineering teams.
Where to find product info
FDA recall page Z-2568-2025 and Abiomed recall communications.
What timeline to expect
Remedy processing timelines vary; expect weeks to months for refunds or replacements.
If the manufacturer is unresponsive
- Escalate to hospital administration
- File a complaint with the manufacturer and FDA if needed
- Consult an attorney if any damages occur
How to prevent similar issues
- Verify device specifications before use
- Maintain updated recall contact lists at facilities
- Work with clinicians to ensure device integrity before deployment
Documentation advice
Keep recall notice, device identifiers, batch numbers, and all correspondence.
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Product Details
Brand: Abiomed. Product: Automated Impella Controller (AIC). Models/Codes: 0042-0000-US, 0042-0000-US-L, 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, 0042-0000-UK-L. Sold to US states: AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH, PA, TX. International distribution: Canada, Germany, Great Britain, Italy, Netherlands, Norway. Recall date: 2025-08-20. Status: ACTIVE. Hazard level: HIGH. Quantity: 71 units.
Reported Incidents
No specific incident counts are provided in the recall data. The FDA notice indicates a Class I risk.
Key Facts
- 71 total units recalled
- Class I recall
- Pump Driver Circuit Assembly not meeting specifications
- US distribution across 18 states plus multiple regions
- International distribution to Canada, Germany, Great Britain, Italy, Netherlands, Norway
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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