FDA Device recall Z-1470-2026
Impella RP Flex with SmartAssist
- FDA Device
- Class I
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class I recall of Impella RP Flex with SmartAssist by Abiomed, citing differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1470-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-01-27 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Abiomed |
| Distribution | US |
Product
Impella RP Flex with SmartAssist. Product Code: 1000323.
Reason
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Identifiers
| code_info | Product Code: 1000323. UDI-DI: 00813502012811. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1470-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.