Abiomed recalls Impella CP pump sets with potential introducer sheath leakage. Affected units include Pump Set Code 0048-0044 and Introducer Product Code 0052-3046. No remedy specified in official notice.
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 Impella CP heart pump sets that may have introducer sheath leakage. This leakage risk could lead to complications during medical procedures, but the issue isn't visible to users.
The introducer sheath in the pump set can leak fluid from under the sheath cap and along the hub score lines. This leakage is not visible to users and occurs in 14Fr and 23Fr introducers included with every pump set.
Healthcare professionals using Abiomed Impella CP pump sets with specific product codes are affected. Patients receiving these pumps during procedures may be at risk if leakage occurs.
Check for Pump Set Code 0048-0044 and Introducer Product Code 0052-3046 on the packaging or label. All current batches in the field are affected.
Look for Pump Set Code 0048-0044 and Introducer Product Code 0052-3046 on the packaging or label.
The official recall notice does not specify any remedy.
Check for Pump Set Code 0048-0044 and Introducer Product Code 0052-3046 on the packaging or label.
The risk is potential introducer sheath leakage that could lead to complications during medical procedures, but this issue is not visible to users.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2691-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2691-2026 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.
