The Recall Desk
HighFDA (Devices)·Z-1346-2022·Announced 2022-07-20

CoolMax ZELTIQ Vacuum Applicator recalled for paradoxical hyperplasia complaints

Zeltiq Aesthetics is voluntarily discontinuing 2,945 CoolMax ZELTIQ Vacuum Applicators due to an increase in paradoxical hyperplasia complaints between 2019 and 2021, an adverse event causing unwanted tissue growth instead of intended fat reduction.

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: This is an FDA Class II device recall with documented adverse events (increased complaints of paradoxical hyperplasia). The hazard represents actual risk of tissue disfigurement. However, no hospitalizations, severe injuries, or deaths are reported in the source, and the recall is voluntary and precautionary rather than mandated.

Plain-English summary

Zeltiq Aesthetics, Inc is executing a voluntary discontinuation and removal of the CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000. A total of 2,945 units have been distributed throughout the United States and internationally.

The recall is due to an increase in complaints of paradoxical hyperplasia (HP) occurring during the 2019 to 2021 timeframe. Paradoxical hyperplasia is an adverse event in which the device causes unwanted tissue growth instead of the intended fat reduction through cryolipolysis.

The recalled product

Product
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Manufacturer
Zeltiq Aesthetics, Inc
Category
Medical Device — Aesthetic contouring device
Hazard
Affected units
2,945

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 →

Related recalls

Same manufacturer · Zeltiq Aesthetics, Inc

See all →