On July 11, 2022, the FDA posted that the manufacturer of CoolSculpting has recalled five of its CoolSculpting applicators due to an increased risk of Paradoxical Adipose Hyperplasia (PAH).
According to the US Food & Drug Administration, Zeltiq Aesthetics, Inc. (also known as Allergan Aesthetics and Abbvie, Inc.), the manufacturer of CoolSculpting and CoolSculpting Elite products has issued a voluntary recall of the CoolMax, CoolCore, CoolFit, CoolCurve+, and the Cool Curve vacuum applicators. The FDA published a notice stating that these CoolSculpting medical devices are being recalled: “due to an increase in the rate of complaints for Paradoxical hyperplasia (PH) (also referred to as Paradoxical Adipose Hyperplasia-PAH) during 2019 to 2021 timeframe.” The recall requests that all CoolSculpting providers with these devices immediately stop using them and return them to the manufacturer.
As part of this recall, the manufacturer of CoolSculpting told the FDA that on June 9, 2022, it began sending out “URGENT: MEDICAL DEVICE RECALL” letters via FedEx Overnight mail to med spas and doctors’ offices who own the CoolSculpting device. The recall letter instructs the users to “discontinue and return all CoolSculpting Parallel Plate Applicators (CoolCore, CoolCurve, CoolCurve+, CoolMax, and CoolFit) due to an increase in the rate of complaints for Paradoxical hyperplasia (PH) (also referred to as Paradoxical Adipose Hyperplasia-PAH) during 2019 to 2021 timeframe.”
How does the CoolSculpting recall affect consumers?
Many CoolSculpting providers may still be using the recalled CoolSculpting devices. If you already got the CoolSculpting procedure, you should call your CoolSculpting provider to discuss this recall. You should also monitor the treatment area closely for any signs of Paradoxical Adipose Hyperplasia (PAH).
How does the CoolSculpting recall affect CoolSculpting providers?
According to the manufacturer of CoolSculpting, providers should stop using the affected applicators on their patients and return the devices per the manufacturer’s instructions. According to the FDA, the manufacturer should have notified CoolSculpting providers about this recall and provided specific instructions on how to return the recalled devices to the manufacturer. If you did not receive a recall notification, you should contact the manufacturer of CoolSculpting or the FDA for further information.
Where can I find more information about the CoolSculpting recall?
A separate notice was issued on the FDA’s Medical Device Recalls website for each affected CoolSculpting Applicator. You can find additional information here.
Is the CoolSculpting recall global?
Health Canada issued a similar notice regarding the CoolSculpting recall, stating that all lots of the affected CoolSculpting applicators (Coolcore, Coolcurve, Coolcurve+, Coolmax, and Coolfit applicators) are being recalled and discontinued by Zeltiq Aesthetics, Inc.
Regulatory agencies from other countries and regions published similar notices about the CoolSculpting recall, including Hong Kong, Malaysia, and the United Kingdom.
The CoolSculpting recall affects all 50 states within the United States as well as Washington DC and Puerto Rico.
The CoolSculpting recall also affects countries around the world, including United Arab Emirates, Argentina, Austria, Australia, Belgium, Bahrain, Bolivia, Canada, Switzerland, China, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, The Republic of Korea, Kuwait, Lebanon, Luxembourg, Latvia, Mexico, The Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Sweden, Singapore, Thailand, Turkey, Taiwan, Uruguay, Venezuela, and South Africa
Has the manufacturer of CoolSculpting publicly announced the recall?
Based on our investigation, the manufacturer of CoolSculpting has not publicly announced the voluntary recall of the CoolSculpting applicators. The CoolSculpting website, which advertises the procedure does not have any information about the global recall.
Why should consumers know about the CoolSculpting recall?
In this blog post, Attorney Louiza Tarassova discusses why she believes the CoolSculpting recall should have been announced by the manufacturer to the public.
