CoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports
Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: Class II medical device with documented adverse event reports of Paradoxical Hyperplasia (abnormal fat growth at treatment sites) during 2019–2021. The reported complaints of this significant adverse event and the documented pattern of increase warrant a Severe rating.
Plain-English summary
The product being recalled is the CoolCurve+ ZELTIQ Vacuum Applicator (reference BRZ-AP1-064-000), manufactured by Zeltiq Aesthetics, Inc. Approximately 2,686 units have been distributed worldwide, including throughout the United States and 52 other countries.
Zeltiq Aesthetics is voluntarily discontinuing and removing these applicators due to an increased complaint rate for Paradoxical Hyperplasia (HP) during the 2019–2021 timeframe. Paradoxical Hyperplasia is an adverse event characterized by unexpected fat growth or enlargement in treated areas.
Patients who received treatment with the recalled applicators should contact their healthcare provider if they experience symptoms consistent with Paradoxical Hyperplasia, such as persistent or progressive swelling or firmness in previously treated areas. A physician can evaluate the condition and recommend appropriate management.
The recalled product
- Product
- CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
- Manufacturer
- Zeltiq Aesthetics, Inc
- Affected units
- 2,686
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
- HighCoolFit ZELTIQ Vacuum Applicator recalled for increased Paradoxical Hyperplasia complaints
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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