Abiomed recalls Oscor Introducer Kits (14Fr x Short Individual) due to potential breach in sterile packaging that could lead to infections. Affected units sold with part number 0052-3014. Consumers should 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 Oscor Introducer Kits (14Fr x Short Individual) because holes in the packaging might let bacteria into the device, risking infections for patients. This is serious because it could cause infections like sepsis if the device isn't properly sterile.
The kits' outer pouches may have holes that break the sterile seal. This could let bacteria enter the bloodstream during medical procedures, causing infections like sepsis or bacteremia.
Patients using this medical device for Impella catheter procedures are most at risk. The recall affects specific models sold with part number 0052-3014.
Check for the part number 0052-3014 on the kit packaging. These kits are intended for Impella catheter procedures and were sold with this specific part number.
Reach out to Abiomed directly for instructions on how to handle the recalled kit.
The recall is due to potential holes in the packaging that could compromise the sterile barrier, risking infections like sepsis.
Check for part number 0052-3014 on the kit packaging.
The recall does not specify an immediate stop-use requirement; contact Abiomed for instructions.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0647-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0647-2024 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.
