This is part of a larger recall. The most authoritative record is FDA-Device / Z-2681-2026.
Abiomed Insertion Kit heart pump accessory recalled for introducer sheath leakage risk
What this means
Abiomed's Insertion Kit for heart pump systems contains introducer sheaths that may leak fluid from under the cap or along internal seams. This manufacturing defect is not visible to users and affects 14Fr and 23Fr introducers included in every pump set.
- Contact Abiomed immediately if you use or manage this pump system.
- Do not use the affected introducer kit until you receive guidance from Abiomed.
- Provide your pump set code (0052-0011-JP) and introducer code (0052-3006-JP) to Abiomed or your healthcare provider when you call.
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-2692-2026More 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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