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Impella
Abiomed, Inc. · Model 1000323 · UDI-DI 00813502012811
PYX
Prescription
0
510(k) clearances
2,151
Adverse events (410 deaths)
7
Recalls
2
Facilities
Description
RP Flex w Smart Assist Set, US
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-27 | Abiomed, Inc. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. |
| 2026-01-27 | Abiomed, Inc. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. |
| 2026-01-27 | Abiomed, Inc. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. |
| 2024-12-12 | Abiomed, Inc. | Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Ven |
| 2024-12-12 | Abiomed, Inc. | Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Ven |
| 2023-12-06 | Abiomed, Inc. | The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; |
| 2023-06-29 | Abiomed, Inc. | A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas m |
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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.