ABIOMED Impella 5: recall status

⚠ Recalls found. ABIOMED Impella 5 is named in 2 official recalls in our current data:

• FDA Class I recall Z-2687-2026 — 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 visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
• FDA Class I recall Z-2688-2026 — 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 visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.