Abiomed recalls 14Fr Introducer Kits with potential sterile barrier holes that could cause infections. Affected kits may lead to bacteremia or sepsis if used without proper sterility.
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 14Fr Introducer Kits that may have holes in their sterile packaging. This could let bacteria enter the bloodstream, causing infections like sepsis. Patients using these kits need to stop using them immediately.
The kits' sterile packaging may have holes that allow bacteria to enter the bloodstream. This can lead to infections like sepsis or bacteremia, especially during medical procedures where sterility is critical.
Healthcare professionals using the Abiomed 14Fr Introducer Kits for cardiac procedures are most at risk. Patients receiving these kits during procedures could face infections.
Check for the product name 'Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual' with part number 0052-0053. These kits were sold for cardiac procedures.
Discard the Abiomed 14Fr Introducer Kits if you have them.
Holes in the sterile packaging could let bacteria enter the bloodstream, leading to infections like sepsis or bacteremia.
Check for the product name 'Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual' with part number 0052-0053.
The recall record does not specify a return process, so contact Abiomed directly for disposal instructions.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0651-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0651-2024 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.
