Abiomed recalls Impella CP Smart Assist Set (Pump Set Code 0048-0024-JP) due to potential introducer sheath leakage. This risk may cause complications during medical procedures. Affected units include all current batches in field.
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 Smart Assist Set (Pump Set Code 0048-0024-JP) because of a potential leak in the introducer sheath. This leak could cause complications during medical procedures, but the issue is not visible to users and only affects specific sizes of introducers.
The introducer sheath may leak from under the sheath cap and along the hub score lines. This leakage could cause complications during medical procedures, but the issue is not visible to users and only affects specific sizes of introducers.
Patients using the Impella CP Smart Assist Set for heart support are affected. Medical professionals using the 14Fr or 23Fr introducers in the pump set are most at risk.
Check for Pump Set Code 0048-0024-JP and Introducer Product Code 0052-3025-JP on the device. All current batches in field are affected.
Look for Pump Set Code 0048-0024-JP and Introducer Product Code 0052-3025-JP on the device.
Yes, if your device has Pump Set Code 0048-0024-JP and Introducer Product Code 0052-3025-JP, it is affected.
The issue is not visually detectable by users. Only the 14Fr or 23Fr introducers in the pump set are affected.
The recall 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-2690-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2690-2026 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.
