Abiomed recalls 14Fr Introducer Kits with potential sterile barrier holes that could cause infections. Affected kits may expose patients to microorganisms, leading to sepsis or bacteremia. 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 certain sterile introducer kits that may have holes in their outer pouch, risking infection. This could lead to serious infections like sepsis or bacteremia if the kits are used without a proper sterile barrier.
Holes in the outer pouch of the sterile introducer kits can compromise the sterile barrier. This allows non-sterile material to enter the bloodstream, potentially causing infections like sepsis or bacteremia.
Patients using Abiomed's 14Fr Introducer Kits for Impella catheter procedures are at risk. Healthcare providers using these kits for vascular access are most vulnerable.
Check for part numbers 0048-0040, 0048-0045, or 1000080 on the kit packaging. These kits are used with Impella catheters and are sold for vascular access procedures.
Look for part numbers 0048-0040, 0048-0045, or 1000080 on the kit packaging to identify affected units.
The recall indicates potential holes in the sterile barrier that could lead to infections. Affected kits should not be used until the issue is resolved.
The recall does not specify a remedy, so contact Abiomed directly for guidance on next steps.
No, the recall states that holes in the sterile barrier could cause infections, so affected kits should not be used.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0652-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0652-2024 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.
