Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, ZELTIQ Aesthetics, Inc., has issued a medical device safety alert concerning its ZELTIQ Cryolipolysis Skin Contouring System [CoolCore Applicator (BRZ-AP1-063-000); CoolCurve Applicator (BRZ-AP1-062-000); CoolCurve+ Applicator (BRZ-AP1-064-000); CoolMax Applicator (BRZ-AP1-080-000); CoolFit Applicator (BRZ-AP1-066-000)] [HKMD No.: 190025].
The manufacturer is voluntarily globally discontinuing and recalling CoolSculpting parallel plate applicators (CoolCore, CoolCurve, CoolCurve+, CoolMax, and CoolFit applicators) due to the observance of a slightly increased rate of Paradoxical Hyperplasia (PH) during a recent analysis of data from the 2019-2021 timeframe.
According to the manufacturer, the safety profile of CoolSculpting is well characterized. Paradoxical hyperplasia (PH) is a rare adverse event associated with cryolipolysis that is defined as a visibly enlarged tissue volume within the treatment area, which may develop two to five months after treatment and may require surgical intervention for correction. PH is described in the CoolSculpting and CoolSculpting Elite labeling as a rare side effect occurring in approximately 1 out of 3,000 treatments (0.033%).
The manufacturer closely monitors PH reporting rates. The historical and overall rate of PH for CoolSculpting since launch in 2010 to 2021 is within the predicted frequency. In a recent analysis of reported complaints during the 2019 to 2021 timeframe, however, the data showed an increase in the rate of PH with the CoolSculpting parallel plate applicators (approximately 1 out of 1,000 treatments), which is at the upper limit of the predicted frequency. Therefore, the recall is limited only to the parallel plate applicators because the analysis of data from the 2019-2021 timeframe show an increase in the rate specified in the labeling.
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 May 2022