Recall Z-0646-2024 ยท DYB Introducer, Catheter
Abiomed, Inc.
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)
| Date | Jan 5, 2024 (initiated Nov 7, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Process control |
| Action | Abiomed issued URGENT MEDICAL DEVICE RECALL (REMOVAL) Letter Products Impacted: Introducer Kit for Impella (sold within Impella Pump sets and Individually Packaged) Axillary Introducer Kits on 11/7/23. Letter states reason for recall, health risk and action to take: IF AN IMPELLA PUMP IS CLINICALLY NEEDED, ACTIONS TO BE TAKEN BY THE USER: 1. Prior to usage, carefully examine the outer pouch of the Introducer Kit for holes following the provided instructions in Attachment 2. 2. For non-trayed introducers (Part Numbers 0052-3006): IF THERE IS ANY SUSPICION OF THIS TYPE OF PACKAGING DAMAGE, REFRA |
| Quantity | 717 single units; 1906 within sets |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192769 | Impella CP Introducer Abiomed, Inc., Nov 18, 2019 |