Abiomed Impella CP Introducer Kit recalled for potential fluid leakage
Abiomed Impella CP Introducer Kit recalled for leakage risk
Abiomed has recalled the Impella CP Introducer Kit (Pump Set Code 1000550) worldwide due to a potential for fluid leakage from under the sheath cap and along hub score lines in the 14Fr and 23Fr introducers. The leakage defect is not visible to the user and affects all current batches of this heart pump accessory kit.
- If you have received or implanted this device, contact your healthcare provider or Abiomed immediately
- Do not use additional kits from affected batches without consulting your clinical team
- Report any observed leakage or complications to Abiomed and the FDA MedWatch program
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-2683-2026More Abiomed, Inc. recalls
- FDA-Device2026-07-22Abiomed Impella CP heart pump introducer recalled for potential sheath leakage
- FDA-Device2026-07-22Abiomed Impella CP heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella 5.5 SmartAssist S2 heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella RP Flex heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella 5.5 Smart Assist Set recalled for introducer sheath leakage risk
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