Abiomed recalls axillary insertion introducers with potential holes in sterile packaging that could let bacteria enter the bloodstream. Patients may face infections 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 axillary insertion introducers that may have holes in their sterile packaging. This could let bacteria enter the bloodstream, causing infections or sepsis in patients during medical procedures.
The introducer kits may have holes in their outer pouch, breaking the sterile barrier. This allows non-sterile materials to enter the bloodstream, potentially causing infections, bacteremia, or sepsis.
Patients undergoing medical procedures using these introducers are at risk. Healthcare providers using the product for Impella catheter insertion are most affected.
Check for part number 0052-3006 on the introducer kit. These were sold as part of pump sets with specific part numbers including 005062 and others.
Look for holes in the outer pouch of the sterile packaging to determine if the kit is compromised.
Holes in the sterile packaging could allow bacteria to enter the bloodstream, leading to infections or sepsis.
Check for part number 0052-3006 on the introducer kit. These were sold as part of pump sets with specific part numbers including 005062.
Check for holes in the outer pouch of the packaging. If holes are present, contact Abiomed for guidance.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0646-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0646-2024 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.
