Abiomed recalls certain Oscor Introducer Kits due to potential hole in sterile packaging that could allow bacteria into the bloodstream, causing infection. Affected kits may need replacement to prevent sepsis.
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 specific Oscor Introducer Kits that may have holes in their sterile packaging. This could let bacteria enter the bloodstream, leading to infections like sepsis. If you have the recalled kit, stop using it and contact Abiomed for a replacement.
The sterile packaging of the Introducer Kit may have holes that allow bacteria to enter the bloodstream. This could cause infections like sepsis, which is a serious medical condition requiring immediate treatment.
Patients who use the Abiomed Oscor Introducer Kit for heart support procedures are most at risk. Healthcare providers who administer the kit may also be affected if they have the recalled model.
Check for the product name 'Abiomed Oscor Introducer Kit, 14Fr x Long Individual' with part number 0052-3015. The recall covers kits sold with the model code 0052-0017.
If you have the recalled kit, stop using it immediately to prevent potential infection.
Reach out to Abiomed directly for a replacement kit or other assistance.
The recalled model is Abiomed Oscor Introducer Kit, 14Fr x Long Individual with part number 0052-3015.
Check for the product name 'Abiomed Oscor Introducer Kit, 14Fr x Long Individual' with part number 0052-3015.
Yes, the recall states that holes in the sterile packaging could lead to infections like sepsis, which requires immediate medical attention.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0648-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0648-2024 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.
