Class IOngoingZ-2691-2026
Abiomed, Inc. recalls ABIOMED Impella CP Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
2026 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 397–408 of 2,088 recalls
Class IOngoingZ-2690-2026
Abiomed, Inc. recalls ABIOMED Impella CP Smart Assist Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2689-2026
Abiomed, Inc. recalls ABIOMED Impella CP Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2688-2026
Abiomed, Inc. recalls ABIOMED Impella 5.5 SmartAssist S2 Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2687-2026
Abiomed, Inc. recalls ABIOMED Impella 5.5 Smart Assist Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2686-2026
Abiomed, Inc. recalls ABIOMED Impella CP Introducer Kit 14 Fr
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2685-2026
Abiomed, Inc. recalls ABIOMED Impella CP Introducer Kit 14 Fr
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2684-2026
Abiomed, Inc. recalls ABIOMED Introducer Kit 23 Fr
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2683-2026
Abiomed, Inc. recalls ABIOMED Impella CP Introducer Kit 14 Fr
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2682-2026
Abiomed, Inc. recalls ABIOMED Impella CP Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2681-2026
Abiomed, Inc. recalls ABIOMED Impella RP Flex with SmartAssist Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2680-2026
Oscor Inc. recalls Abiomed REF: 0052-3006
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Oscor Inc.FLJul 22, 2026