Fresh Recalls

ABIOMED Impella CP Introducer Kit 14 Fr: recall status

⚠ Recalls found. ABIOMED Impella CP Introducer Kit 14 Fr is named in 3 official recalls in our current data:

Brand
Abiomed

Recalls naming this model

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella CP Introducer Kit 14 Fr recall status

Official ID Z-2683-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella CP Introducer Kit 14 Fr recall status

Official ID Z-2685-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Company / brand: Abiomed recalls

Affected product: ABIOMED Impella CP Introducer Kit 14 Fr recall status

Official ID Z-2686-2026 · Official record ↗

See all Abiomed recalls →

Verify with the official sources:

Found something wrong or missing? Report a data error.

Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.