This is part of a larger recall. The most authoritative record is FDA-Device / Z-2681-2026.
Abiomed Impella CP Introducer Kit recalled for potential sheath leakage
What this means
Abiomed has recalled the Impella CP Introducer Kit (14 Fr, 13 cm) due to a manufacturing defect that can cause fluid leakage from under the sheath cap and along the hub. The defect is not visible to users and affects introducers included in every pump set.
- If you have received or are using this introducer kit, contact Abiomed immediately for guidance on your specific unit.
- Do not use the device until you have confirmed with Abiomed that your batch is not affected or have received replacement instructions.
- Check the pump set code (0052-0038) and introducer product code (0052-3052) on your device to verify if it is part of this recall.
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-2685-2026More 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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