Abiomed recalls certain Introducer Kits that may have holes in the sterile pouch, 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
Abiomed is recalling specific Introducer Kits that may have holes in the sterile pouch, which could allow bacteria to enter the bloodstream and cause infections. This is serious because infections can lead to sepsis or bacteremia in patients.
The Introducer Kits may have holes in the outer pouch, breaking the sterile barrier. This allows non-sterile materials to enter the bloodstream, potentially causing infections like sepsis or bacteremia.
Patients using these Introducer Kits for Impella Catheter procedures are at risk. Healthcare providers who use the kits for medical procedures are most vulnerable.
Check for product names: Abiomed KIT, 14 Fr Introducer, 13 & 25 cm. The part numbers are 0048-0024 or 0048-0032. These kits were sold as part of the Impella Pump Set.
Discard the Introducer Kits if you have them to prevent infection risks.
The recalled kits are Abiomed KIT, 14 Fr Introducer, 13 & 25 cm with part numbers 0048-0024 or 0048-0032.
Check for the part numbers 0048-0024 or 0048-0032 on the Introducer Kits, which are part of the Impella Pump Set.
Holes in the sterile pouch could allow bacteria to enter the bloodstream, causing infections like sepsis or bacteremia.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0654-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0654-2024 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.
