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, PREGNANT, 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 Flex with SmartAssist RVAD
- Model numbers
- Product Code: 1000323. UDI-DI: 00813502012811.
- 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 Flex with SmartAssist is a percutaneous right ventricular assist device used to support patients with severe heart failure. It provides short-term circulatory support via catheter-based therapy.
Why This Is Dangerous
A malfunctioning differential pressure sensor can drift readings, potentially impairing device function and patient management.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The recall affects patient safety and may require urgent medical decision-making. Healthcare providers must assess device status and communicate replacement options.
Practical Guidance
How to identify if yours is affected
- Check Product Code 1000323 and UDI-DI 00813502012811
- Confirm device belongs to Impella RP Flex with SmartAssist
- Review recall notice for country distribution and recall date
Where to find product info
FDA recall page and Abiomed communications; manufacturer contact
What timeline to expect
Remedy timeline not specified; coordinate with Abiomed for replacement or remediation timelines
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact FDA CDRH complaint line if manufacturer is unresponsive
- Document all attempts at contact
How to prevent similar issues
- Verify device recalls during procurement and ongoing clinical use
- Maintain up-to-date device inventory with serial numbers and UDI-DI
- Follow manufacturer safety advisories for similar devices
Documentation advice
Keep recall letter, device serial numbers, model numbers, and all correspondence with Abiomed or clinicians
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product Code: 1000323 UDI-DI: 00813502012811 Distribution: Worldwide, including US nationwide and Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland Units recalled: 4,496 Recall date: 2026-01-27 Manufacturer: Abiomed, Inc.
Key Facts
- Global distribution including US nationwide
- Differential pressure (dP) sensor drift risk
- Class I recall
- Model: Product Code 1000323; UDI-DI 00813502012811
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.