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
- Right Ventricular Assist Device (RVAD) - Impella RP
- Model numbers
- Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.
- 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 is a percutaneous right ventricular assist device used to temporarily support the heart’s right ventricle in patients with certain heart conditions.
Why This Is Dangerous
A malfunctioning differential pressure sensor can produce drift in readings, potentially affecting clinical decisions and patient safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
Hospitals must halt use of the affected devices and follow recall procedures. There could be patient care disruptions while devices are removed or replaced.
Practical Guidance
How to identify if yours is affected
- Check device product code 0046-0011 on the device label and packaging.
- Verify the UDI-DI 04260113630273.
- Confirm distribution country and that the device matches the recall notice.
Where to find product info
UDI label on device packaging and the packaging insert; product labeling.
What timeline to expect
Remedy timeline not specified in the notice. Follow manufacturer instructions and the recall letter; consult the FDA page for updates.
If the manufacturer is unresponsive
- Escalate through hospital procurement or regulatory authorities if the manufacturer is unresponsive.
- Document all communications and seek guidance from the hospital risk management department.
How to prevent similar issues
- Implement recall registry procedures to quickly identify affected lots or product codes in inventory.
- Verify UDI during procurement to ensure future purchases are within supported lots.
- Monitor for recall updates from the FDA and the manufacturer.
Documentation advice
Keep the recall notice, product code, UDI, and any correspondence with the manufacturer. Document device serial numbers and disposition actions.
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Product Details
Model numbers: Product Code 0046-0011; UDI-DI 04260113630273. Where sold: Hospitals and healthcare facilities worldwide, including US nationwide and listed countries. When sold: Unknown. Price: Unknown.
Key Facts
- Worldwide distribution including US and listed countries
- Hazard: differential pressure sensor drift
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Safety Guide
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