FDA Device Intelligence
Home › Device types › PYX

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA product code PYX · Class 3 · Cardiovascular

9
Registered devices
2,151
Adverse events
7
Recalls
0
510(k) clearances

Devices with this code

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

DateFirmReason
2026-01-27Abiomed, Inc.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
2026-01-27Abiomed, Inc.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
2026-01-27Abiomed, Inc.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
2024-12-12Abiomed, 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
2024-12-12Abiomed, 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
2023-12-06Abiomed, Inc.The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notification
2023-06-29Abiomed, 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

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 docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.