Abiomed Impella CP heart pump recalled for introducer sheath leakage risk
What this means
Abiomed has recalled the Impella CP heart pump due to a potential for fluid leakage from the introducer sheath (a tube inserted during the procedure). The leakage can occur under the sheath cap or along connection points, and these defects cannot be seen by the user. All current batches of the pump set are affected worldwide.
- If you have received or are using an Impella CP pump set, contact Abiomed immediately for guidance.
- Do not use the pump set until you have spoken with Abiomed or your healthcare provider.
- Your hospital or clinic may have specific instructions; follow their direction.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2691-2026More Abiomed recalls
- FDA-Device2026-07-22Abiomed Introducer Kit 23 Fr recalled for potential sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella CP Smart Assist Set recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Intro Kit heart pump introducer recalled for potential fluid leakage risk
- FDA-Device2026-07-22Abiomed Impella 5.5 Smart Assist Set recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella RP Flex heart pump recalled for introducer sheath leakage risk
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