Zeltiq recalls CoolMax ZELTIQ Vacuum Applicators with specific serial numbers due to increased reports of Paradoxical Hyperplasia (HP) between 2019-2021. This condition involves abnormal tissue growth that may require medical attention.
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 CoolMax ZELTIQ Vacuum Applicators (serial numbers listed) because they have been linked to Paradoxical Hyperplasia (HP), a condition where tissue grows abnormally in response to the device. This recall is based on reports from 2019 to 2:19, and users should stop using the device if they have the affected model.
The device has been reported to cause Paradoxical Hyperplasia (HP), a condition where tissue grows abnormally in response to the device's use. HP is a rare but serious condition that may require medical treatment if it occurs.
Users of the CoolMax ZELTIQ Vacuum Applicator with the listed serial numbers (from 2019-2021) are at risk of Paradoxical Hyperplasia. This condition is rare but can cause tissue growth that may require medical intervention.
Check if your CoolMax ZELTIQ Vacuum Applicator has a serial number starting with 'V08' followed by 10 digits (e.g., V082010246001). The recall covers specific serial numbers listed in the official notice.
Look for the serial number on your CoolMax ZELTIQ Vacuum Applicator, which starts with 'V08' followed by 10 digits.
If your device has a serial number in the list provided, stop using it immediately and contact Zeltiq for instructions.
Paradoxical Hyperplasia (HP) is a rare condition where tissue grows abnormally in response to the device. It may require medical treatment if it occurs.
Check the serial number on your CoolMax ZELTIQ Vacuum Applicator. It starts with 'V08' followed by 10 digits. The affected models are listed in the official recall notice.
The recall does not specify a return process; users should contact Zeltiq directly for instructions if they have an affected device.
We’ve drafted a message you can send Zeltiq to request your refund or repair — edit it as you like.
Subject: Recall Z-1346-2022 — Zeltiq Zeltiq Hello, I own a Zeltiq that is covered by recall Z-1346-2022 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.
