Edwards Lifesciences, LLC: Medical Device Recall in 2018 - (Recall #: Z-1929-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 30, 2018

Date Posted: May 30, 2018

Recall Number: Z-1929-2018

Event ID: 79650

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.

Status: Terminated

Product Quantity: 3,052 units total

Code Information:

Lot No. 60876468, 60850885, 6060850886, 60850888, 60850889, 60850890, 60887217, 60887218, 60887219, 60887220, 60930494, 60934623, 60934624, 60934625, 60972889, 60972890, 60972892, 61014406, 61014408, 61014410, 61014411, 61050171, 61050172, 61078031, 61078032, 61097633, 61139239, 61139240, 61139241, 61139242, 61184964, 61184965, 67784966, 61184967, 61204586, 61204587, 61259626, 61259627, 61259628, and 61259629.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated