FDA Device recall Z-1469-2026
Impella RP 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 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-1469-2026 |
| 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 with SmartAssist. Product Code: 0046-0035.
Reason
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Identifiers
| code_info | Product Code: 0046-0035. UDI-DI: 00813502011869. |
|---|
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-1469-2026%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.