Recall Z-1350-2022— Zeltiq Aesthetics, Inc

Name: FDA recall Z-1350-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-09

Class II · Ongoing

Class II FDA medical device recall by Zeltiq Aesthetics, Inc, initiated 2022-06-09. It names one FDA 510(k) clearance: K181740. Product: CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000. Reason: 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..

Recalling firm: Zeltiq Aesthetics, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-06-09
Firm location: Pleasanton, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K181740 — ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.·cleared 2018-08-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.