Abiomed recalls Impella CP pump sets with potential introducer sheath leakage. Affected units have specific product codes and batch numbers. Contact for remedy details.
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 could cause complications during medical procedures, but the issue isn't visible to users.
The introducer sheath (a thin tube used during procedures) may leak fluid from under the sheath cap and along the hub score lines. This leakage is caused by manufacturing issues that aren't visible to the user and affects 14Fr and 23Fr introducers in every pump set.
Patients using the Impella CP heart pump system for cardiac support are most at risk. Healthcare providers who use the pump set with the affected introducers may also be affected.
Check for product codes 0048-0014 (pump set) and 0052-3046 (introducer). The pump sets are sold with specific batch numbers and GTINs listed in the recall notice.
Look for pump set code 0048-0014 and introducer code 0052-3046 on the packaging or label.
The recall addresses a potential for sheath leakage that could cause complications during medical procedures, but the issue isn't visible to users and doesn't cause immediate harm.
Check for product codes 0048-0014 (pump set) and 0052-3046 (introducer) on the packaging or label.
The recall notice 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-2689-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2689-2026 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.
