Abiomed Impella 5.5 SmartAssist S2 heart pump recalled for introducer sheath leakage risk
What this means
Abiomed has recalled certain Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a manufacturing defect in the introducer sheaths. The 14Fr and 23Fr introducers included in these pump sets may leak fluid from under the sheath cap or along hub seams, and the leakage cannot be seen by the user before or during use.
- If you have received or implanted one of these pump sets (Codes 1000459 or 1000460), contact Abiomed immediately for instructions.
- Do not use the pump set if you have not yet received it.
- Healthcare providers should follow Abiomed's guidance on patient management and device replacement.
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-2688-2026More 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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