FDA Device recall Z-1349-2022
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000 by Zeltiq Aesthetics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1349-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-09 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Zeltiq Aesthetics |
| Distribution | 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, WY |
Product
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
Reason
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.
Identifiers
| code_info | CoolCurve+ REF: BRZ-AP1-064-000 BRZ-AP1-064-000_R UDI-DI: 00816417020193 Serial Numbers: V0642017122012 V06420162850…CoolCurve+ REF: BRZ-AP1-064-000 BRZ-AP1-064-000_R UDI-DI: 00816417020193 Serial Numbers: V0642017122012 V0642016285020 V0642016285018 V0642016173010 V0642016173009 V0642016173007 V0642016173005 V0642016173003 V0642016173002 V0642016173001 V0642016167020 V0642016167019 V0642016167018 V0642016167017 V0642016167015 V0642016167013 V0642016167011 V0642016167009 V0642016167007 V0642016167006 V0642016167002 V0642016167001 V0642016160019 V0642016160018 V0642016160017 V0642016160014 V0642016160013 V0642016160012 V0642016160009 V0642016160008 V0642016160005 V0642016160003 V0642016160002 V0642016127020 V0642016127019 V0642016127018 V0642016127017 V0642016127016 V0642016127014 V0642016127013 V0642016127011 V0642016127008 V0642016127006 V0642016127005 V0642016127004 V0642016127001 V0642016125019 V0642016125018 V0642016125017 V0642016125016 V0642016125015 V0642016125014 V0642016125013 V0642016125011 V0642016125010 V0642016125009 V0642016125008 V0642016125007 V0642016125006 V0642016125005 V0642016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1349-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.