CoolFit ZELTIQ Vacuum Applicator recalled for increased Paradoxical Hyperplasia complaints
Zeltiq Aesthetics is voluntarily discontinuing the CoolFit ZELTIQ Vacuum Applicator due to an increased complaint rate for the adverse event Paradoxical Hyperplasia observed during 2019-2021.
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 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: FDA Class II recall with documented increase in complaints for an adverse event (Paradoxical Hyperplasia) during 2019-2021. Although no hospitalizations or deaths are reported in the source, the increased complaint rate indicates a significant medical concern warranting high-severity classification.
Plain-English summary
Zeltiq Aesthetics, Inc. is executing a voluntary discontinuation and removal of the CoolFit ZELTIQ Vacuum Applicator (model REF BRZ-AP1-066-000) due to an increase in complaint rate for the adverse event Paradoxical Hyperplasia (HP). The increase in complaints was observed during the 2019 to 2021 timeframe.
Approximately 2,684 units were distributed in the United States and internationally. Users of the affected devices should discontinue their use. Patients treated with the affected equipment should contact their healthcare provider with any concerns regarding complications.
The recalled product
- Product
- CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
- Manufacturer
- Zeltiq Aesthetics, Inc
- Hazard
- Affected units
- 2,684
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
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- 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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