Dermal Cooling Pack/Vacuum/Massager
FDA adverse event reports and recall history for dermal cooling pack/vacuum/massager (product code OOK), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 11,334
- Deaths
- 2
- Injuries
- 11,124
- Malfunctions
- 205
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2021-08-27TerminatedSoftware design
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without being aware that a thermal event has occurred.
- Open, ClassifiedUnknown/Undetermined by firm
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
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.
- Open, ClassifiedUnknown/Undetermined by firm
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
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.
- Open, ClassifiedUnknown/Undetermined by firm
CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
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.
- Open, ClassifiedUnknown/Undetermined by firm
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
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.
- Open, ClassifiedUnknown/Undetermined by firm
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
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.
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