# FDA recall Z-1348-2024

> **Angiodynamics, Inc.** · Class II · device recall initiated 2024-01-30.

## Product

MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system.			-					    Catalog Number: 45-781

## Reason for recall

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

## Distribution

Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL,  NO, NZ, ZA.

## Key facts

- **Recall number:** Z-1348-2024
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-30
- **Report date:** 2024-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Queensbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1348-2024

## Citation

> AI Analytics. FDA recall Z-1348-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1348-2024. Source: US FDA. Licensed CC0.

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