# FDA recall Z-2448-2019

> **LeMaitre Vascular, Inc.** · Class II · device recall initiated 2019-07-24.

## Product

The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.

## Reason for recall

incorrect device size being listed on the impacted device packaging

## Distribution

GERMANY  FRANCE  SLOVENIA  SPAIN  SWEDEN  UK

## Key facts

- **Recall number:** Z-2448-2019
- **Recalling firm:** LeMaitre Vascular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-24
- **Report date:** 2019-09-11
- **Termination date:** 2020-05-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2448-2019

## Citation

> AI Analytics. FDA recall Z-2448-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2448-2019. Source: US FDA. Licensed CC0.

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