Freedom System Accessories 00-52004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850051034208), received between Aug 28, 2024 and Mar 17, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

6 other recalls cover devices cleared under the same FDA submission (K152178); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Use of Device Problem

  THE PATIENT REPORTED IRRITATION AND BUBBLING ON THEIR SKIN UNDERNEATH WHERE THE WEARABLE IS WORN. TOPICAL OINTMENT WAS USED AND AS OF (B)(6) 2026, THE SKIN IS HEALING. THE COMMERCIAL TEAM MEMBER INSTRUCTED THE PATIENT TO WEAR THE WEARABLE OVER A SOCK OR PANTS AND TO NOT PLACE IT DIRECTLY ON THE SKIN. THE PATIENT HAS A FOLLOW UP APPOINTMENT ON (B)(6) 2026. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24618691 ↗
• InjuryFeb 18, 2026Use of Device Problem

  THE PATIENT REPORTED CONSISTENTLY GETTING A RASH WHILE WEARING THE WEARABLE. THE PATIENT REPORTED USING AN ALLERGY OINTMENT AND HAS NOT BEEN USING HE DEVICE. AS OF (B)(6) 2026, THE RASH HAS BEEN RESOLVED AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Rash

  MAUDE report 24379547 ↗
• InjuryJun 25, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED THEIR WEARABLE WAS CAUSING AN ALLERGIC REACTION TO THEIR SKIN WHICH RESULTED IN SKIN DERMATITIS AND SMALL BLISTER LIKE PUSTULES AROUND THE AREA OF THE WEARABLE. AN ANTIBIOTIC OINTMENT WAS PRESCRIBED AND THE AREA WAS COVERED WITH GAUZE. THE PATIENT WAS INSTRUCTED TO REFRAIN FROM WEARING THE DEVICE FOR A FEW DAYS AND WILL WEAR A BARRIER BETWEEN THE WEARABLE AND THEIR SKIN. THE PATIENT NOTICED THE FORMATION OF NEW BLISTERS ON (B)(6) 2025 AND WAS SEEN BY THEIR DERMATOLOGIST ON (B)(6) 2025. THE PATIENT'S BLISTERS HAVE STARTED TO HEAL, CULTURES OF THE AREA WERE OBTAINED, AND ANTIBIOTICS WERE PRESCRIBED. THE RESULTS OF THE CULTURES ARE NOT AVAILABLE AT THIS TIME AND FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Blister; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 22331697 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR WEARABLE IS CAUSING SKIN IRRITATION. THE COMMERCIAL TEAM MEMBER SUGGESTED OTHER NON-CURONIX BRAND WEARABLES. THERAPY IS WORKING WELL FOR THE PATIENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20091868 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152178. One submission often covers many models, so check the product and lot details in each record.

• Z-2933-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic re
• Z-2930-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief
• Z-2928-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relie
• Z-2929-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractabl
• Z-2931-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractab
• Z-2932-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractabl