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 but 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 its Impella CP Introducer Kit 14Fr models because they can leak from under the sheath cap and along the hub score lines. This leakage risk could lead to 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, though the problem isn't visible to users.
Patients using the Impella CP Introducer Kit 14Fr models for heart pump support are affected. Medical professionals who use these kits during procedures are at the highest risk.
Check for the Impella CP Introducer Kit 14Fr, 13 cm, Pump Set Code 0052-0038, with Introducer Product Code 0052-3052. All current batches in the field are affected.
Identify the Pump Set Code 0052-0038 and Introducer Product Code 0052-3052 on the kit.
No, only the specific 14Fr model with Pump Set Code 0052-0038 and Introducer Product Code 0052-3052 is affected.
No, the leakage issue is not visually detectable by the user.
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-2685-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2685-2026 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.
