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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- paradoxical-hyperplasia
- adverse-event
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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