The Recall Desk
HighFDA (Devices)·Z-1350-2022·Announced 2022-07-20

CoolFit ZELTIQ Vacuum Applicator recalled for increased Paradoxical Hyperplasia complaints

Zeltiq Aesthetics is voluntarily discontinuing the CoolFit ZELTIQ Vacuum Applicator due to an increased complaint rate for the adverse event Paradoxical Hyperplasia observed during 2019-2021.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with documented increase in complaints for an adverse event (Paradoxical Hyperplasia) during 2019-2021. Although no hospitalizations or deaths are reported in the source, the increased complaint rate indicates a significant medical concern warranting high-severity classification.

Plain-English summary

Zeltiq Aesthetics, Inc. is executing a voluntary discontinuation and removal of the CoolFit ZELTIQ Vacuum Applicator (model REF BRZ-AP1-066-000) due to an increase in complaint rate for the adverse event Paradoxical Hyperplasia (HP). The increase in complaints was observed during the 2019 to 2021 timeframe.

Approximately 2,684 units were distributed in the United States and internationally. Users of the affected devices should discontinue their use. Patients treated with the affected equipment should contact their healthcare provider with any concerns regarding complications.

The recalled product

Product
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
Manufacturer
Zeltiq Aesthetics, Inc
Category
Medical Device — Aesthetic Equipment
Hazard
Affected units
2,684

Distribution

Distributed in 52 states:

Part of a larger recall action

This product is one of 5 recalled by Zeltiq Aesthetics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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