Abiomed recalls Oscor Intro Kit (14Fr x 13 and 25 cm) due to potential hole in sterile packaging that could allow bacteria into the bloodstream. Affected patients may face infection or sepsis. Contact Abiomed for details.
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
Abiomed is recalling its Oscor Intro Kit (14Fr x 13 and 25 cm) because holes in the sterile packaging could let bacteria enter the bloodstream, risking infections or sepsis. This is serious for patients using the kit for heart support.
The Introducer Kits may have holes in their outer pouch, breaking the sterile barrier. This could let bacteria enter the bloodstream during catheter insertion, causing infections, bacteremia, or sepsis.
Patients using the Oscor Intro Kit for Impella catheter procedures are most at risk. The recall affects individuals who have the specific kit model with part number 0052-3025.
Check for the Oscor Intro Kit (14Fr x 13 and 25 cm) with part number 0052-3025. The product is part of Abiomed's Impella pump system.
Immediately stop using the Oscor Intro Kit if you have it, as it could lead to infections or sepsis.
The recalled product is the Oscor Intro Kit (14Fr x 13 and 25 cm) with part number 0052-3025.
Patients using the kit could face infections or sepsis if bacteria enter the bloodstream through the compromised sterile packaging.
The recall record does not mention a fix or remedy; the product must be stopped use immediately.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0653-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0653-2024 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.
