OZDFDA Class 3
Temporary Non-Roller Type Left Heart Support Blood Pump
Device family · Unknown
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
127
Manufacturers
1
Flagged signals
12
Adverse-event reports
39,643
Code matrix
| FDA product code | OZD |
| Device class | Class 3 |
| Regulation | — |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | Yes |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Death | 2025 | 3 | 28.4 | 55 |
| Death | 2026 | 10 | 16.2 | 129 |
| Death | 2026 | 148 | 13.0 | 1,640 |
| Death | 2025 | 350 | 12.0 | 3,557 |
| Death | 2026 | 263 | 9.0 | 1,888 |
| Death | 2025 | 1,333 | 4.8 | 4,064 |
| Death | 2025 | 147 | 4.8 | 447 |
| Death | 2024 | 97 | 3.2 | 145 |
| Death | 2025 | 35 | 3.1 | 47 |
| Death | 2025 | 32 | 2.8 | 36 |
| Death | 2022 | 76 | 2.5 | 67 |
| Death | 2022 | 582 | 2.1 | 338 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 39,643 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Abiomed, Inc. | 127 | 2026 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Impella 5.5 with Smart Assist · Abiomed, Inc.PMA · 2026-04-07
Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5 with Smart A · Abiomed, Inc.PMA · 2026-02-06
Impella CP with SmartAssist; Impella 5.5 with SmartAssist · Abiomed, Inc.PMA · 2025-12-19
Impella 5.5 with SmartAssist · Abiomed, Inc.PMA · 2025-10-01
Impella CP with SmartAssist · Abiomed, Inc.PMA · 2025-09-24
Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD · Abiomed, Inc.PMA · 2025-09-19
Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette · Abiomed, Inc.PMA · 2025-09-15
Impella CP with SmartAssist System · Abiomed, Inc.PMA · 2025-08-08
Impella 5.5 with SmartAssist System; Impella CP with SmartAssist System; Impella 2.5; Impella 5.0; Impella LD; · Abiomed, Inc.PMA · 2025-08-01
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD · Abiomed, Inc.PMA · 2025-07-25
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD · Abiomed, Inc.PMA · 2025-06-23
IMPELLA CP with Smart Assist · Abiomed, Inc.PMA · 2025-06-20
Impella CP with SmartAssist · Abiomed, Inc.PMA · 2025-02-04
Impella CP with SmartAssist, Impella 5.5 with SmartAssist · Abiomed, Inc.PMA · 2024-12-03
Impella CP with SmartAssist · Abiomed, Inc.PMA · 2024-10-29
Impella 5.5 with SmartAssist · Abiomed, Inc.PMA · 2024-10-21
Impella CP with SmartAssist, Impella 5.5 with SmartAssist · Abiomed, Inc.PMA · 2024-09-12
Impella CP, Impella CP with SmartAssist, Impella 2.5, Impella 5.0/LD, Impella 5.5 with SmartAssist · Abiomed, Inc.PMA · 2024-01-05
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist Systems · Abiomed, Inc.PMA · 2023-12-21
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist · Abiomed, Inc.PMA · 2023-11-29
Impella CP with SmartAssist · Abiomed, Inc.PMA · 2023-06-27
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist · Abiomed, Inc.PMA · 2023-06-14
Impella 2.5, Impella CP and CP with SmartAssist · Abiomed, Inc.PMA · 2023-04-27
Impella CP with SmartAssist · Abiomed, Inc.PMA · 2023-04-13
Impella Ventricular Support Systems · Abiomed, Inc.PMA · 2023-03-29
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.