Abiomed recalls sterile introducer kits that may have holes compromising the sterile barrier, risking infection. Affected kits could expose patients to microorganisms, leading to sepsis or bacteremia.
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
Abi:med recalls sterile introducer kits that may have holes in the outer pouch, risking infection. If the sterile barrier is compromised, patients could get infections like sepsis or bacteremia.
Holes in the outer pouch of the kits can break the sterile barrier. This allows non-sterile material to enter the bloodstream, potentially causing infections like sepsis or bacteremia.
Patients using Abiomed's 23Fr Introducer Kits for Impella Catheter procedures are at risk. Healthcare providers using these kits for vascular access are most vulnerable.
Check for Abiomed 23Fr Introducer Kits with part number 2000342. These kits are used with Impella Catheters for vascular access procedures.
Inspect the outer pouch for holes that could compromise the sterile barrier.
The recall states that holes in the sterile barrier could lead to infections like sepsis or bacteremia, but does not specify a risk of serious injury in normal use.
Look for Abiomed 23Fr Introducer Kits with part number 2000342 used with Impella Catheters for vascular access.
The recall does not specify a remedy, so check the kit for holes and contact Abiomed if concerned.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0655-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0655-2024 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.
