Recall Z-0653-2024— Abiomed, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abiomed, Inc., initiated 2023-11-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025. 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.
- Recalling firm
- Abiomed, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-07
- Firm location
- Danvers, MA, United States
Product description
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.