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U.S. Department of Health and Human Services

Class 2 Device Recall The CoolSculpting System

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  Class 2 Device Recall The CoolSculpting System see related information
Date Initiated by Firm June 09, 2022
Create Date July 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-1348-2022
Recall Event ID 90331
510(K)Number K181740  
Product Classification Dermal cooling pack/vacuum/massager - Product Code OOK
Product CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
Code Information CoolCurve REF: BRZ-AP1-062-000 BRZ-AP1-062-000_R UDI-DI: 00816417021008 Serial Numbers: V06222012073001 V0622017039030 V0622016307004 V0622016196017 V0622012291003 V0622012289006 V0622012289004 V0622012289002 V0622012285005 V0622012285002 V0622012284009 V0622012284001 V0622012283003 V0622012282002 V0622012279006 V0622012279005 V0622012278001 V0622012277004 V0622012262002 V0622012258007 V0622012258002 V0622012255002 V0622012254001 V0622012250004 V0622012212001 V0622012210007 V0622012201001 V0622012193004 V0622012192004 V0622012178002 V0622012173001 V0622012170007 V0622012167003 V0622012167002 V0622012165008 V0622012163002 V0622012161005 V0622012161003 V0622012161002 V0622012160001 V0622012159007 V0622012159002 V0622012156004 V0622012153006 V0622012152001 V0622012150004 V0622012150002 V0622012150001 V0622012145003 V0622012145002 V0622012144001 V0622012143009 V0622012143008 V0622012143007 V0622012143006 V0622012143005 V0622012143002 V0622012140002 V0622012139005 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Recalling Firm/
Zeltiq Aesthetics, Inc
4410 Rosewood Dr
Pleasanton CA 94588-3050
For Additional Information Contact Nicole Katz
Manufacturer 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.
FDA Determined
Cause 2
Unknown/Undetermined by 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 recall@qualanex.com 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 IR-Medcom@allergan.com For after hours assistance, please leave a voicemail or email. A response will be provided within 48 hours.
Quantity in Commerce 703 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OOK and Original Applicant = ZELTIQ Aesthetics, Inc.