Abiomed Impella CP heart pump recalled for introducer sheath leakage risk
What this means
Abiomed has recalled the Impella CP heart pump set due to a manufacturing defect in the introducer sheath that can cause leakage. The leakage can occur under the sheath cap or along hub score lines in the 14Fr and 23Fr introducers included with every pump set, and the defect is not visible to users.
- If you have an Abiomed Impella CP pump set, contact Abiomed or your healthcare provider immediately for guidance.
- Do not use affected units until you receive instructions from Abiomed or your clinical team.
- Check the product code 0048-0014 and introducer code 0052-3046 on your pump set packaging.
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-2689-2026More 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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