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Impella
Abiomed, Inc. · Model 0042-0000-US · UDI-DI 00813502010022
0
510(k) clearances
44,301
Adverse events (5,667 deaths)
43
Recalls
3
Facilities
Description
Impella Controller, Packaged, US
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 circulatory support. |
| 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 been implemented th |
| 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 (0550-0008*) pumps. |
| 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 performance or pump stop |
| 2025-06-23 | Abiomed, Inc. | A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.