Open, Classified

CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000

FDA Recall Z-1346-2022 · Posted None

Recall StatusOpen, Classified

Product CodeOOK

Date Initiated2022-06-09

Product Quantity2,945 units

Reason for Recall

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.

Firm Action

On 06/09/2022, the Recalling firm started sending an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx Overnight service to customers informing them 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. Customers are instructed to: 1. If you have the affected applicators, discontinue further use and quarantine products prior to return. 2. Monitor patients that have undergone a procedure per your normal clinical practice. . 3. Conduct a physical count of the affected applicators in your possession and record the count on the enclosed Business Response Form. 4. Send the Business Response Form to Qualanex, LLC. via fax or email within five business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form. Please return the Business Response Form even if no recalled product is present. 5. When returning the recalled products, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton and return the recalled product to: Qualanex, LLC. 1410 Harris Road Libertyville, IL 60048 5. Please do not return any products that are not the subject of this recall to this address. For questions or assistance, contact: Product Returns Contact Qualanex, LLC 1-800-505-9291, 7:00am - 4:00pm CST or [email protected] Adverse Events/Product Complaints Contact ZELTIQ at: 1-800-624-4261, 8am 5pm CST Medical Information Contact ZELTIQ at: 1-800-678-1605 option #2, 8:30 am 5:00 pm EST or [email protected] For after hours assistance, please leave a voicemail or email. A response will be provided within 48 hours.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

U.S. 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, and WY. O.U.S.: 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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2018-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.