Z-1929-2018 Class II Terminated
FDA device recall Z-1929-2018 was initiated by Edwards Lifesciences, LLC on Mar 30, 2018 and is designated Class II. 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. The recall status is terminated (terminated Nov 29, 2023). Affected quantity: 3,052 units total.
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- Mar 30, 2018
- Termination Date
- Nov 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,052 units total
Product Description
Reason for Recall
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1929-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026