Zeltiq recalls CoolCore ZELTIQ Vacuum Applicators with serial numbers starting with V0632018... due to increased reports of Paradoxical Hyperplasia (HP) from 2019-2021. Affected units may cause skin growths if used improperly.
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 CoolCore ZELTIQ Vacuum Applicators (serial numbers starting with V0632018) because they've been linked to Paradoxical Hyperplasia (HP), a skin growth condition, during use from 2019 to 2021. This recall is based on increased reports of this adverse event.
Paradoxical Hyperplasia (HP) is a rare skin condition where abnormal tissue growth occurs. The recall indicates that the CoolCore ZELTIQ Vacuum Applicator has been associated with increased reports of this condition during the 2019-2021 timeframe. While HP is uncommon, it can cause skin growths that may require medical attention.
Users of the CoolCore ZELTIQ Vacuum Applicator with serial numbers starting with V0632018 (as listed in the recall) are most at risk. This device is used for medical treatments, so patients and healthcare providers who have purchased or used the affected units should check if they are included.
Check if your CoolCore ZELTIQ Vacuum Applicator has a serial number starting with V0632018 (e.g., V0632018051020, V0632018051019, etc.). The recall covers specific units identified by these serial numbers.
Look for the serial number on your CoolCore ZELTIQ Vacuum Applicator. If it starts with V0632018, it is affected.
Paradoxical Hyperplasia (HP) is a rare skin condition where abnormal tissue growth occurs. The recall indicates that the CoolCore ZELTIQ Vacuum Applicator has been associated with increased reports of this condition during the 2019-2021 timeframe.
Check if your CoolCore ZELTIQ Vacuum Applicator has a serial number starting with V0632018 (e.g., V0632018051020, V0632018051019, etc.).
No action is needed if your device's serial number does not start with V0632018.
We’ve drafted a message you can send Zeltiq to request your refund or repair — edit it as you like.
Subject: Recall Z-1347-2022 — Zeltiq Zeltiq Hello, I own a Zeltiq that is covered by recall Z-1347-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
