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 affects all current batches.
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 may leak from under the sheath cap and along the hub score lines. This leakage could lead to complications during medical procedures, but 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 isn't visible to users.
Patients using Abiomed Impella CP Introducer Kit 14Fr models for heart pump procedures are most at risk. Healthcare providers who use these kits in medical settings may also be affected.
Check for the product code 0052-0039 on the Impella CP Introducer Kit 14Fr, 25 cm model. All current batches in the field are affected by this issue.
Look for the product code 0052-0039 on the Impella CP Introducer Kit 14Fr, 25 cm model.
No, this recall specifically affects the 14Fr Impella CP Introducer Kit 25 cm model with product code 0052-0039.
No, the leakage issue is not visually detectable by the user.
The leakage could lead to complications during medical procedures, but the issue is not visible to users and does not pose an immediate risk of serious injury.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2686-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2686-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
