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
- 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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