# FDA recall Z-1929-2018

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2018-03-30.

## Product

Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device.  Packaged in a sterile barrier system.  Model Number: ICF100.    Designed to occlude the ascending aorta.

## Reason for recall

Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.

## Distribution

Worldwide Distribution -- USA, to the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MI, MS, MO, NV, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV; and, the countries of to Australia, Austria, Belgium, Canada, Colombia, Czech Republic, France, Germany, Israel, Italy, Luxembourg, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-1929-2018
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-30
- **Report date:** 2018-05-30
- **Termination date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Draper, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1929-2018

## Citation

> AI Analytics. FDA recall Z-1929-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1929-2018. Source: US FDA. Licensed CC0.

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