Edwards Lifesciences, LLC: Medical Device Recall in 2019 - (Recall #: Z-1705-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: May 14, 2019

Date Posted: June 19, 2019

Recall Number: Z-1705-2019

Event ID: 82870

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.

Status: Terminated

Product Quantity: 6552

Code Information:

All lot numbers.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated