Oscor recalls Abiomed 14F Introducer Kits with potential leaks in sheaths. Affected kits have specific lot numbers and may require replacement.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Oscor is recalling Abiomed Introducer Kits for Impella Hemostatic Peel Away Systems. The kits could leak from the sheaths, which might cause bleeding or other complications during medical procedures.
The sheaths could leak fluid from the sidearm, under the cap, or along the hub. This might lead to bleeding or other complications during medical procedures if the leak is not detected.
Medical professionals using the Abiomed Introducer Kit for Impella systems are likely affected. Patients undergoing procedures with these kits may be at risk if leaks occur.
Check for the Abiomed Introducer Kit with model number 0052-3025. The kits have specific lot numbers: 00885672009793 or 00813502010664.
Look for lot numbers 00885672009793 or 00813502010664 on the kit packaging.
The recall is for medical use only; it does not apply to home users.
Check the lot numbers: 00885672009793 or 00813502010664 on the Abiomed Introducer Kit model 0052-3025.
The recall does not specify a remedy, so contact Oscor for guidance.
We’ve drafted a message you can send Oscor to request your refund or repair — edit it as you like.
Subject: Recall Z-2678-2026 — Oscor Oscor Hello, I own a Oscor that is covered by recall Z-2678-2026 from Oscor. 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.
