Zeltiq recalls CoolCurve+ ZELTIQ Vacuum Applicators with serial numbers starting with V064201... due to increased reports of Paradoxical Hyperplasia (HP) from 2019-2021. Stop using immediately to avoid potential complications.
Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
Zeltiq is recalling specific CoolCurve+ ZELTIQ Vacuum Applicators (serial numbers starting with V064201...) because they've been linked to Paradoxical Hyperplasia (HP) in users from 2019 to 2021. This condition can cause abnormal tissue growth that may require medical intervention. Affected users should stop using the device immediately.
The recall is based on increased reports of Paradoxical Hyperplasia (HP) in users of this device between 2019 and 2021. HP is a condition where tissue grows abnormally in response to the device, potentially requiring medical intervention. The device is designed for skin treatments but the specific model has a higher risk of this complication.
Users of the CoolCurve+ ZELTIQ Vacuum Applicator with serial numbers starting with V064201... (as listed in the recall) are most at risk. This device is used for skin treatments and is typically owned by individuals seeking cosmetic procedures.
Check if your CoolCurve+ ZELTIQ Vacuum Applicator has a serial number starting with V064201... (e.g., V0642017122012, V0642016285020, etc.). The recall covers specific serial numbers listed in the official notice.
Immediately stop using the CoolCurve+ ZELTIQ Vacuum Applicator with the affected serial numbers to prevent potential complications from Paradoxical Hyperplasia.
Paradoxical Hyperplasia (HP) is a condition where tissue grows abnormally in response to the device, potentially requiring medical intervention. It has been reported in users of this specific CoolCurve+ ZELTIQ Vacuum Applicator model from 2019 to 2021.
Check if your CoolCurve+ ZELTIQ Vacuum Applicator has a serial number starting with V064201... (e.g., V0642017122012, V0642016285020, etc.). The recall covers specific serial numbers listed in the official notice.
The recall does not specify a return process, but you should stop using the device immediately to avoid potential complications.
We’ve drafted a message you can send Zeltiq to request your refund or repair — edit it as you like.
Subject: Recall Z-1349-2022 — Zeltiq Zeltiq Hello, I own a Zeltiq that is covered by recall Z-1349-2022 from Zeltiq. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
