CoolCore BRZ-AP1-063-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00816417020179), received between Jul 27, 2023 and Aug 21, 2023 — classified as 12 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-1347-2022 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 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 ABDOMEN ON (B)(6) 2016 USING LEGACY COOLCORE APPLICATOR, TO UPPER AND LOWER FLANKS ON (B)(6) 2016 USING COOLCORE APPLICATOR AND TO ABDOMEN ON (B)(6) 2016 USING COOLCOREAPPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA IN ABDOMEN DIAGNOSED ON (B)(6) 2016.

  Patient problems: Hyperplasia

  MAUDE report 17584639 ↗
• 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 FLANKS (LOVE HANDLES AND BRA BULGE ON (B)(6) 2014 USING COOLCORE APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA AFTER TREATMENT.

  Patient problems: Hyperplasia

  MAUDE report 17499513 ↗
• 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 MALE PATIENT TREATED WITH COOLSCULPTING TO LOWER ABDOMEN ON (B)(6) 2014 USING COOLCORE APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA AFTER TREATMENT.

  Patient problems: Hyperplasia

  MAUDE report 17498905 ↗
• InjuryAug 9, 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 ABDOMEN ON (B)(6) 2016 WITH COOLMAX APPLICTOR AND MID ABDOMEN WITH COOLCORE APPLICATOR. ON (B)(6) 2015 TO THE LOWER ABDOMEN USING COOLMAX AND COOLCORE APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA AFTER TREATMENT.

  Patient problems: Hyperplasia

  MAUDE report 17492444 ↗
• InjuryAug 7, 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 TREATED WITH COOLSCULPTING TO THE LOWER ABDOMEN ON (B)(6) 2017 USING COOLCORE, (B)(6) 2018 TO THE LOWER ABDOMEN USING COOLCORE APPLICATOR AND ON (B)(6) 2018 TO THE FLANKS USING COOLCOURVE+ APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA ON LOWER ABDOMEN AND FLANKS ON (B)(6) 2018 AFTER TREATMENT.

  Patient problems: Hyperplasia

  MAUDE report 17475008 ↗
• InjuryAug 7, 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) 2015 USING COOLCORES AND THE FLANKS USING COOLCURVE PLUS WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) IN THE LOWER ABDOMEN DIAGNOSED (B)(6) 2015.

  Patient problems: Hyperplasia

  MAUDE report 17470918 ↗
• 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) 2012, WITH 6.3 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 17426082 ↗
• 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 FEMALE PATIENT WHO WAS TREATED WITH COOLSCULPTING ON (B)(6) 2012, WITH 6.3 APPLICATOR TO THE LOWER ABDOMEN. ON (B)(6) 2012 THE PATIENT WAS TREATED AGAIN. IT WAS RULED OUT UNCONFIRMED-PH AND INSUFFICIENT INFO REPORTABLE.

  Patient problems: Hyperplasia

  MAUDE report 17425254 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT FROM THE FEMALE PATIENT WHO WAS TREATED WITH COOLSCULPTING ON (B)(6) 2012 WITH WITH EZ APP 6.3 APPLICATOR TO THE LOWER AND UPPER ABDOMEN. THE PATIENT WAS ASSESSED BY A PHYSICIAN WHO DIAGNOSED THE LOWER AND UPPER ABDOMEN WITH PARADOXICAL HYPERPLASIA.

  Patient problems: Hyperplasia

  MAUDE report 17412818 ↗
• InjuryJul 27, 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 TREATED ON (B)(6) 2015 TO THE BILATERAL LOWER ABDOMEN WITH COOLCORE + WHO DEVELOPED PARADOXICAL HYPERPLASIA (PH) DESCRIBED AS 'SIGNIFICANT GROWTH OF FAT IN THE AREA. IT'S FIRMER THAN THE SURROUNDING FAT TISSUE, THERE'S A CLEAR DIFFERENCE IN THE "HARDNESS" OF THE FAT.'

  Patient problems: Hyperplasia

  MAUDE report 17408441 ↗
• InjuryJul 27, 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 THE 6.3 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 17406075 ↗
• InjuryJul 27, 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 ON (B)(6)2012 TO THE LOWER ABDOMEN, UPPER ABDOMEN AND LOVE HANDLES. ALLERGAN MEDICAL SAFETY DEEMED THE REPORTED EVENTS AS UNCONFIRMED-PH DUE TO INSUFFICIENT INFORMATION AND SERIOUS IN SEVERITY.

  Patient problems: Hyperplasia

  MAUDE report 17404541 ↗