FDA Medical devices recall ·
Impella RP with SmartAssist recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1469-2026
- Date
- (initiated January 27, 2026)
- Company / brand
- Abiomed, Inc.
22 Cherry Hill Dr, Danvers, MA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 291 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Impella RP with SmartAssist. Product Code: 0046-0035.
Why was it recalled?
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Code: 0046-0035. UDI-DI: 00813502011869.
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1469-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.