Home › Device types › OZD
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA product code OZD · Class 3 · Unknown
23
Registered devices
44,301
Adverse events
43
Recalls
0
510(k) clearances
Devices with this code
Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella CP with SmartAssist — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.Impella — Abiomed, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-18 | Abiomed, Inc. | Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulat |
| 2026-05-14 | Abiomed, Inc. | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices. |
| 2026-04-20 | Abiomed, Inc. | A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have |
| 2026-02-18 | Abiomed, Inc. | Increased risk of purge leaks with Generation 1 purge cassettes. |
| 2026-02-16 | Abiomed, Inc. | Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (055 |
| 2025-12-04 | Abiomed, Inc. | Device packaged in incorrect outer box carton. |
| 2025-10-01 | Abiomed, Inc. | Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC). |
| 2025-09-16 | Abiomed, Inc. | Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. |
| 2025-08-20 | Abiomed, Inc. | Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump perfo |
| 2025-06-23 | Abiomed, Inc. | A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.