CoolCurve+ Applicator BRZ-AP1-064-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816417020193), received between Aug 7, 2023 and Aug 7, 2023 — classified as 1 injury.

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-1349-2022 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 THE LOWER RIGHT AND LEFT ABDOMEN USING A COOLCORE APPLICATOR BOTH ON (B)(6) 2016 USING WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) AFTER TREATMENT. PH WAS DIAGNOSED ON (B)(6) 2018 AND WAS DESCRIBED AS FIRM, WELL DEFINED AND FEELS DIFFERENT.

  Patient problems: Hyperplasia

  MAUDE report 17469103 ↗