# FDA recall Z-1705-2019

> **Edwards Lifesciences, LLC** · Class I · device recall initiated 2019-05-14.

## Product

IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO     The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.

## Reason for recall

Possibility of balloon rupture in intra-aortic occlusion devices.  If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.

## Distribution

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

## Key facts

- **Recall number:** Z-1705-2019
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-14
- **Report date:** 2019-06-19
- **Termination date:** 2024-04-23

- **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-1705-2019

## Citation

> AI Analytics. FDA recall Z-1705-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1705-2019. Source: US FDA. Licensed CC0.

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