Abiomed recalls Impella CP Introducer Kit 14Fr models due to potential sheath leakage from under the sheath cap and along hub score lines. This issue is not visible to users and may cause complications during medical procedures.
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.
Abiomed is recalling certain Impella CP Introducer Kits because they can leak from under the sheath cap and along the hub score lines. This leakage could cause complications during medical procedures, even though the issue isn't visible to users.
The introducer sheath can leak from under the sheath cap and along the hub score lines due to manufacturing issues. This leakage may cause complications during medical procedures, but the problem is not visible to users.
Patients using the Impella CP heart pump system with the recalled introducer kits are most at risk. Healthcare providers who use these kits for medical procedures may also be affected.
Check for the Impella CP Introducer Kit 14Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm. The product has a GTIN: 00813502013474 and is part of all current batches in the field.
Identify if your kit has Pump Set Code 1000550 and Introducer Product Code 0052-3046.
This recall specifically affects the Impella CP Introducer Kit 14Fr models. If you have the pump set with Pump Set Code 1000550, you are affected.
The issue is not visible to users, so you cannot tell by appearance. Check the product code and GTIN on the packaging.
The recall record does not specify a remedy, so contact Abiomed directly for guidance.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2683-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2683-2026 from Abiomed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
