# FDA recall Z-0646-2024

> **Abiomed, Inc.** · Class II · device recall initiated 2023-11-07.

## 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 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

## 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

## Key facts

- **Recall number:** Z-0646-2024
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-07
- **Report date:** 2024-01-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danvers, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0646-2024

## Citation

> AI Analytics. FDA recall Z-0646-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0646-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*