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 risk
What this means
Abiomed has recalled certain Impella CP Introducer Kits due to a potential manufacturing defect that could cause the introducer sheath to leak from under the cap or along the hub seams. This defect is not visible to users and affects all current batches of the product worldwide.
- If you have an affected Impella CP Introducer Kit (Pump Set Code 0052-0039 or Introducer Product Code 0052-3053), contact Abiomed immediately for instructions.
- Do not use the product until you have confirmed your unit is not affected or have received replacement guidance.
- Check the product code and GTIN numbers (00813502011715, 00813502012736) on your kit.
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-2686-2026More 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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