CoolMax Applicator BRZ-AP1-080-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00816417020230), received between Jul 26, 2023 and Aug 21, 2023 — classified as 11 injuries.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 9, 2022Open, Classified

   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.

   Z-1346-2022 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO LOWER ABDOMEN ON (B)(6) 2016 WAS TREATED WITH LEGACY COOLMAX APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA IN ABDOMEN DIAGNOSED ON UNKNOWN DATE AND MONTH IN 2016.

  Patient problems: Hyperplasia

  MAUDE report 17587516 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE RIGHT AND LEFT UPPER ABDOMEN ON (B)(6) 2015 USING COOLCORE, TO THE LEFT/RIGHT LOWER ABDOMEN ON (B)(6) 2015 USING COOLCORE, TO THE LOWER ABDOMEN ON (B)(6) 2016 USING COOLMAX, TO THE UPPER ABDOMEN ON (B)(6) 2016 USING COOLMAX WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) TO THE UPPER/LOWER ABDOMEN ON AN UNKNOWN DATE POST-TREATMENT AND WAS DIAGNOSED ON (B)(6) 2016. (B)(6).

  Patient problems: Hyperplasia

  MAUDE report 17557635 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT OF A FEMALE PATIENT TREATED WITH COOLSCULPTING TO THE LOWER BILATERAL ABDOMEN ON (B)(6) 2015 USING COOLMAX APPLICATOR,TO THE UPPER BILATERAL ABDOMEN ON (B)(6) 2015 USING COOLCORE APPLICATOR, TO THE INNER BILATERAL THIGHS ON (B)(6) 2015 USING COOLFIT APPLICATOR AND TO THE RIGHT BRA-LINE ON (B)(6) 2015 USING COOLCURVE+ APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA AFTER TREATMENT.

  Patient problems: Hyperplasia

  MAUDE report 17499136 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING ON (B)(6)2015 WITH LEGACY COOLMAX (B)(6) TO THE LOWER ABDOMEN, WITH LEGACY COOLCORE (B)(6) TO THE BRA LINE (BACK). PATIENT DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) OF THE BRA LINE (BACK) AND LOWER ABDOMEN (ONSET (B)(6)2015) DIAGNOSED (B)(6)2018. (B)(6).

  Patient problems: Hyperplasia

  MAUDE report 17455726 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE LOWER ABDOMEN AND INNER THIGHS ON (B)(6) 2013 USING THE LEGACY ZELTIQ EZ APPLICATOR 8.0 WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) IN THE LOWER ABDOMEN DIAGNOSED ON (B)(6) 2013.

  Patient problems: Hyperplasia

  MAUDE report 17436555 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT OF A MALE PATIENT WHO WAS TREATED WITH COOLSCULPTING ON (B)(6) 2011, WITH EZ APP 8.0 APPLICATOR TO THE LOWER ABDOMEN. THE PATIENT WAS ASSESSED BY A PHYSICIAN WHO DIAGNOSED THE LOWER ABDOMEN WITH PARADOXICAL HYPERPLASIA.

  Patient problems: Hyperplasia

  MAUDE report 17426697 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT OF A FEMALE PATIENT WHO WAS TREATED WITH COOLSCULPTING ON (B)(6) 2012, WITH 8.0 APPLICATOR TO THE UPPER ABDOMEN. ON (B)(6) 2012 THE PATIENT UNDERWENT COOLSCULTPING TO HER FLANKS WITH 6.3 APPLICATOR; AND ON (B)(6) 2012, WITH 8.0 APPLICATOR TO UPPER ABDOMEN. THE PATIENT WAS ASSESSED BY A PHYSICIAN AND WHO DIAGNOSED THE UPPER ABDOMEN WITH PARADOXICAL HYPERPLASIA.

  Patient problems: Hyperplasia

  MAUDE report 17416270 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT OF A FEMALE PATIENT WHO WAS TREATED WITH COOLSCULPTING ON (B)(6) 2012 WITH EZ APP 8.0 APPLICATOR TO THE LOWER ABDOMEN. THE PATIENT WAS ASSESSED BY A PHYSICIAN WHO DIAGNOSED THE LOWER ABDOMEN WITH PARADOXICAL HYPERPLASIA.

  Patient problems: Hyperplasia

  MAUDE report 17413821 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT FROM THE MALE PATIENT WHO WAS TREATED WITH COOLSCULPTING ON (B)(6) 2013 WITH COOLMAX APPLICATOR TO THE LOWER ABDOMEN. ON (B)(6) 2013, THE PATIENT WAS ASSESSED BY A PHYSICIAN WHO DIAGNOSED THE ABDOMEN WITH PARADOXICAL HYPERPLASIA.

  Patient problems: Hyperplasia

  MAUDE report 17398862 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT FROM THE MALE PATIENT WHO WAS TREATED WITH COOLSCULPTING ON (B)(6) 2012 WITH COOLMAX ZELTIQ EZ APP 8.0 APPLICATOR TO THE LOWER ABDOMEN. THE PATIENT WAS ASSESSED BY A PHYSICIAN WHO DIAGNOSED THE ABDOMEN WITH PARADOXICAL HYPERPLASIA.

  Patient problems: Hyperplasia

  MAUDE report 17398858 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT FROM THE PATIENT WHO WAS TREATED WITH COOLSCULPTING ON (B)(6) 2013 WITH 8.0 APPLICATOR TO THE LOWER ABDOMEN. APPLICATORS ARE UNKNOWN. ON (B)(6) 2013 THE PATIENT WAS ASSESSED BY A PHYSICIAN WHO DIAGNOSED THE ABDOMEN WITH PARADOXICAL HYPERPLASIA.

  Patient problems: Hyperplasia

  MAUDE report 17398835 ↗