# FDA recall Z-1100-2019

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2019-01-16.

## Product

Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device     is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation.  The balloon expands to occlude a range of aorta sizes from 20 to 40 mm.      The large central lumen of the IntraClude Device serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root.  The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring.

## Reason for recall

Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.

## Distribution

Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, France Germany, Israel, Italy, Luxembourg, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, UAE, and United Kingdom.

## Key facts

- **Recall number:** Z-1100-2019
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-01-16
- **Report date:** 2019-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1100-2019

## Citation

> AI Analytics. FDA recall Z-1100-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1100-2019. Source: US FDA. Licensed CC0.

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