CoolCore ZELTIQ Vacuum Applicator Voluntarily Recalled Due to Paradoxical Hyperplasia
Zeltiq Aesthetics is voluntarily recalling CoolCore ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia, an adverse effect causing unwanted fat tissue growth. The recall affects 3,054 units distributed across the U.S. and internationally.
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 FDA Class II recall involves reported adverse events with an increased complaint rate for Paradoxical Hyperplasia identified during 2019–2021. The source does not report hospitalizations, serious injuries, or fatalities. The significant cosmetic and tissue-related adverse outcome justifies a High severity rating.
Plain-English summary
Zeltiq Aesthetics, Inc. has voluntarily discontinued and is removing CoolCore ZELTIQ Vacuum Applicator units (reference BRZ-AP1-063-000) from the market. The recall addresses an increase in reported cases of Paradoxical Hyperplasia, an adverse event in which the applicator causes unwanted fat tissue growth instead of the intended reduction.
The company identified this increase in complaint rates between 2019 and 2021. Approximately 3,054 units were distributed throughout the United States and to numerous international locations including Canada, Mexico, the United Kingdom, and other countries worldwide.
Users of affected units should stop using the CoolCore ZELTIQ Vacuum Applicator and contact Zeltiq Aesthetics, Inc. or their healthcare provider for guidance on their individual situations and options. Patients who have experienced symptoms consistent with Paradoxical Hyperplasia following treatment with these applicators should seek medical evaluation.
The recalled product
- Product
- CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
- Manufacturer
- Zeltiq Aesthetics, Inc
- Hazard
- paradoxical-hyperplasia
- unwanted-fat-growth
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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