CoolCurve ZELTIQ vacuum applicators withdrawn due to increased Paradoxical Hyperplasia complaints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.
What this means for you
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
- paradoxical-hyperplasia
Distribution
Distributed in 52 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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