Medical Device Recall: 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
Abiomed, Inc. · November 7, 2023
Reason for Recall
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
Distribution
Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX MY NL NO PA SG TW UK
States Affected
NATIONWIDE
Quantity Affected
1784 single units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0650-2024
Status: ongoing
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