Reported Jan 17, 2024 · Ongoing
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part…
Abiomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 24 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
Abiomed Introducer Kit23 Frw/Hlx Vlv Sterile Individualand Part of Pump Set (0043340046-00350052-0002)
- Part Number0052-3021. Intended for introduction of the Impella Catheter into the body
- Lot codes and dates
- UDI-DI00885672009786
- Amount recalled
- 193 single units; 1034 units within kits
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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