FDA Device recall Z-0646-2024
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body by Abiomed, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0646-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-07 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abiomed |
| Distribution | US |
Product
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
Identifiers
| code_info | UDI-DI: 00885672009755 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0646-2024%22
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