FDA Enforcement
Class II
Ongoing
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)
Recall: Z-0646-2024
·
Reported January 17, 2024
Enforcement
- Recall Number
- Z-0646-2024
- Event ID
- 93501
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Abiomed, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 17, 2024
- Initiation Date
- November 7, 2023
- Classification Date
- January 5, 2024
- Address
- 24 Cherry Hill Dr, Danvers, MA, 01923-2575, United States
Description
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)
Reason
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
Code Info
UDI-DI: 00885672009755
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
Quantity
717 single units; 1906 within sets