Abiomed recalls 14Fr and 23Fr introducer kits 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 pump sets.
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 14Fr and 23Fr introducer kits that may leak from under the sheath cap and along the hub score lines. This leakage could cause complications during medical procedures, but the issue isn't visible to users.
The introducer sheath may leak from under the sheath cap and along the hub score lines due to manufacturing issues. This leakage could lead to complications during medical procedures, but the problem isn't visible to users.
Patients using Abiomed's heart pump systems with the recalled introducer kits are affected. Those with the specific pump set code 0052-0023-JP are most at risk.
Check for pump set code 0052-0023-JP on the packaging or label. The recalled kits include 14Fr x 13 and 25 cm introducers with product code 0052-3025-JP.
Look for product code 0052-3025-JP on the introducer kit packaging or label.
No, only pump sets with code 0052-0023-JP are affected.
No, the issue is not visually detectable by users, so checking the product code is necessary.
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-2693-2026 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2693-2026 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.
