Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046
Reported: January 17, 2024 Initiated: November 7, 2023 #Z-0652-2024
Product Description
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046
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
Details
- Recalling Firm
- Abiomed, Inc.
- Units Affected
- 2551 units within set
- 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
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046. Recalled by Abiomed, Inc.. Units affected: 2551 units within set.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0652-2024.
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