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.
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 3/5 (High).
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
- Affected units
- 2,945
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 →- 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
- ModerateCoolCurve ZELTIQ vacuum applicators withdrawn due to increased Paradoxical Hyperplasia complaints
FDA (Devices) · 2022-07-20
- HighCoolSculpting Elite System Software Error May Misreport Thermal Events
FDA (Devices) · 2021-09-08
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