CoolCurve Applicator BRZ-AP1-062-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816417021008), received between Jul 26, 2023 and Jul 31, 2023 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 9, 2022Class IIOpen, 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-1348-2022 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 6.2 APPLICATOR TO THE BACK BULGE. THE PATIENT WAS ASSESSED BY A PHYSICIAN WHO DIAGNOSED THE LOWER ABDOMEN WITH PARADOXICAL HYPERPLASIA.

  Patient problems: Hyperplasia

  MAUDE report 17425516 ↗
• 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 6.2 COOLCURVE AND 6.3 COOLCORE TO THE ABDOMEN AND FLANKS AND ON (B)(6) 2012 WITH 6.2 COOLCURVE AND 6.3 COOLCORE TO THE ABDOMEN AND FLANKS. THE PATIENT WAS ASSESSED BY A PHYSICIAN WHO DIAGNOSED THE ABDOMEN AND FLANKS WITH PARADOXICAL HYPERPLASIA.

  Patient problems: Hyperplasia

  MAUDE report 17398904 ↗