CoolCurve ZELTIQ vacuum applicators withdrawn due to increased Paradoxical Hyperplasia complaints
Zeltiq Aesthetics is removing 703 CoolCurve ZELTIQ vacuum applicators due to increased complaints of Paradoxical Hyperplasia reported between 2019 and 2021.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall initiated as a voluntary discontinuation due to increased complaint rate for Paradoxical Hyperplasia during 2019–2021. No hospitalizations, serious injuries, or deaths are documented; the action represents a precautionary product removal based on increased adverse event reports.
Plain-English summary
Zeltiq Aesthetics, Inc. is voluntarily discontinuing and removing the CoolCurve ZELTIQ Vacuum Applicator (REF BRZ-AP1-062-000) from use. This aesthetic medical device was designed for non-surgical fat reduction using cooling technology.
The company initiated this recall due to an increase in complaint rates for the adverse event Paradoxical Hyperplasia (HP), which occurred during the 2019 to 2021 timeframe. Paradoxical Hyperplasia is characterized by abnormal fat tissue growth in the treated area following the procedure.
Approximately 703 units of the affected product were distributed in the United States and internationally, including in countries such as Canada, the United Kingdom, Australia, Japan, and numerous others.
Users of the CoolCurve ZELTIQ vacuum applicators are advised to discontinue use and contact Zeltiq Aesthetics for guidance on product removal and any necessary patient follow-up regarding potential Paradoxical Hyperplasia.
The recalled product
- Product
- CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
- Manufacturer
- Zeltiq Aesthetics, Inc
- Hazard
- Affected units
- 703
Distribution
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 →- HighCoolMax ZELTIQ Vacuum Applicator recalled for paradoxical hyperplasia complaints
FDA (Devices) · 2022-07-20
- HighCoolFit ZELTIQ Vacuum Applicator recalled for increased Paradoxical Hyperplasia complaints
FDA (Devices) · 2022-07-20
- SevereCoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports
FDA (Devices) · 2022-07-20
- HighCoolCore ZELTIQ Vacuum Applicator Voluntarily Recalled Due to Paradoxical Hyperplasia
FDA (Devices) · 2022-07-20
- HighCoolSculpting Elite System Software Error May Misreport Thermal Events
FDA (Devices) · 2021-09-08
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