Z-1469-2026 Class I Ongoing
FDA device recall Z-1469-2026 was initiated by Abiomed, Inc. on January 27, 2026 and is designated Class I. Reason for recall: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. The recall status is ongoing. Affected quantity: 291 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2026
- Initiation Date
- January 27, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 291 units
Product Description
Impella RP with SmartAssist. Product Code: 0046-0035.
Reason for Recall
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Code Information
Product Code: 0046-0035. UDI-DI: 00813502011869.