Abiomed, Inc. medical device recall: Impella RP with SmartAssist. Product Code: 0046-0035
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98276
- Recall initiated
- Jan 27, 2026
- Classified by FDA
- Feb 27, 2026
- Posted in Enforcement Report
- Mar 11, 2026
- Recalling firm
- Abiomed, Inc.
- Firm location
- Danvers, MA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jan 27, 2026. FDA classified it 31 days later, on Feb 27, 2026. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland. Abiomed, Inc. has 31 recalls in our records.
Recalled products (3)
Z-1469-2026 Class I Ongoing
Impella RP with SmartAssist. Product Code: 0046-0035.
Codes / lots: Product Code: 0046-0035. UDI-DI: 00813502011869.
Quantity: 291 units
Z-1470-2026 Class I Ongoing
Impella RP Flex with SmartAssist. Product Code: 1000323.
Codes / lots: Product Code: 1000323. UDI-DI: 00813502012811.
Quantity: 4,496 units
Z-1471-2026 Class I Ongoing
Impella RP. Product Code: 0046-0011.
Codes / lots: Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.
Quantity: 179 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98276
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.