CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
Class IIReported ongoing
Distribution: U.S. AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, ...