# FDA recall Z-0649-2024

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

## Product

Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002)	  Part Number:	0052-3021.  Intended for introduction of the Impella Catheter into the body

## 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-0649-2024
- **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-0649-2024

## Citation

> AI Analytics. FDA recall Z-0649-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0649-2024. Source: US FDA. Licensed CC0.

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