Quick Facts at a Glance
- Recall Date
- January 27, 2026
- Hazard Level
- HIGH
- Brand
- Abiomed
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- 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 RP with SmartAssist
- Model numbers
- Product Code: 0046-0035. UDI-DI: 00813502011869.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 27, 2026
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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 RP with SmartAssist is a percutaneous right heart pump designed to support the right ventricle in patients with cardiac impairment. It is distributed worldwide and intended for professional medical use.
Why This Is Dangerous
A malfunctioning differential pressure sensor can produce drift in readings, potentially compromising device performance and patient monitoring.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
For patients with the device, the recall requires immediate cessation of use and coordination with clinicians to assess replacement or monitoring needs.
Practical Guidance
How to identify if yours is affected
- Verify device is Impella RP with SmartAssist
- Check Product Code 0046-0035
- Look for the recall letter and FDA notice
Where to find product info
Device labels include Product Code and UDI; recall details are on the FDA recall page for Z-1469-2026
What timeline to expect
Recall notice by letter; follow manufacturer guidance for remediation
If the manufacturer is unresponsive
- Escalate to hospital device safety officers
- Coordinate with manufacturer for instruction
- File a report with the FDA if advised by clinicians or hospital risk management
How to prevent similar issues
- Verify device labeling before use
- Maintain updated recall communications with suppliers
- Report any device performance concerns to clinicians and manufacturers
- Ensure proper device monitoring during use and after implantation
Documentation advice
Keep recall letter, device labeling, UDI, serial numbers, clinician notes, and correspondence with the manufacturer for records.
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Product Details
Product: Impella RP with SmartAssist. Product Code: 0046-0035. UDI-DI: 00813502011869. Quantity recalled: 291 units. Distribution: Worldwide including US nationwide and the listed countries. Recall date: 2026-01-27. Brand: Abiomed.
Key Facts
- Worldwide distribution including US and Europe
- Hazard: differential pressure sensor drift
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Safety Guide
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