Abiomed Impella CP Smart Assist Set recalled for introducer sheath leakage risk
What this means
Abiomed has recalled its Impella CP Smart Assist Set heart pump due to a potential leak in the introducer sheath (a thin tube used during insertion). The leak can occur under the sheath cap or along seam lines in certain models, but the defect is not visible to the user. All current batches worldwide are affected.
- If you have an Impella CP Smart Assist Set, contact Abiomed or your healthcare provider immediately for instructions.
- Do not use the affected pump set until you receive guidance from your medical team.
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-2690-2026More Abiomed recalls
- FDA-Device2026-09-30Abiomed Impella Controller recalled for firmware and software defects affecting pressure signal accuracy
- FDA-Device2026-09-23Abiomed Impella Optical Controller recalled for purge cassette recognition failure risk
- FDA-Device2026-09-23Abiomed Impella Optical Controller recalled for purge cassette recognition failure
- FDA-Device2026-09-23Abiomed Impella Controller recalled for purge cassette recognition failure risk
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