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FDANovember 7, 2023device

Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

abiomed

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052 — Recall Details · AllClear