Abiomed recalls certain Introducer Kits due to potential sterile barrier compromise, risking infections. Affected kits may expose patients to microorganisms, leading to sepsis or bacteremia. 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 specific Introducer Kits that may have holes in their sterile packaging. This could let bacteria enter the bloodstream, causing serious infections like sepsis. If you own one of these kits, stop using it and contact Abiomed for a replacement.
The Introducer Kits may have holes in their outer pouch, breaking the sterile seal. This allows non-sterile materials to enter the bloodstream, potentially causing infections like sepsis or bacteremia.
Patients using the Abiomed Introducer Kit for heart support may be at risk if the sterile barrier is compromised. Healthcare providers who use these kits for medical procedures are most affected.
Check for part numbers 004334, 0046-0035, or 0052-0002 on the kit's packaging. These kits are intended for use with the Impella Catheter and were sold with the UDI-DI: 00885672009786.
Immediately stop using the recalled Introducer Kit if it has holes in the sterile pouch.
Part numbers 004334, 0046-0035, and 0052-0002 are affected.
Holes in the sterile pouch may compromise the barrier, allowing bacteria to enter the bloodstream and cause infections.
Check the part numbers on the packaging; affected kits have part numbers 004334, 0046-0035, or 0052-0002.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0649-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0649-2024 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.
