Abiomed Impella 5.5 Smart Assist Set recalled for introducer sheath leakage risk
Abiomed Impella 5.5 heart pump recalled for leakage risk
The Abiomed Impella 5.5 Smart Assist Set heart pump contains an introducer sheath that may leak under the cap or along hub seams. This manufacturing defect is not visible to the user but is present in all affected pump sets. The issue affects 383 units distributed worldwide.
- If you have an affected Impella 5.5 pump set, contact your healthcare provider or Abiomed immediately.
- Do not use the device until you receive guidance from Abiomed or your medical team.
- Check your pump set code (1000211 or 1000212) and introducer product code (0052-3006-JP) against the recall notice.
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-2687-2026More Abiomed, Inc. recalls
- FDA-Device2026-07-22Abiomed Impella CP heart pump introducer recalled for potential sheath leakage
- FDA-Device2026-07-22Abiomed Impella CP Introducer Kit recalled for potential fluid 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
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