StimQ Freedom-4A Trial Kit Channel B US w/ Receiver FR4A-TRL-B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818225020709), received between Aug 24, 2021 and Mar 5, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K171366); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT WENT TO THE ER DUE TO SEVERE PAIN AT THEIR INCISION SITE. A DOPPLER ULTRASOUND WAS PERFORMED AND RESULTS WERE NEGATIVE. ALTHOUGH THERE WAS NO REDNESS, DRAINAGE, OR SIGNS OF INFECTION, ANTIBIOTICS WERE PRESCRIBED FOR POSSIBLE INFECTION AND THE PATIENT WAS RESPONDING WELL. ON (B)(6) 2024, THE PATIENT RETURNED TO THE HOSPITAL AT THE DIRECTION OF THEIR PAIN PHYSICIAN TO RECEIVE IV ANTIBIOTICS. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 18835575 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED REDNESS, ITCHINESS AND FLUID AT THE LEAD PULL. ANTIBIOTICS WERE PRESCRIBED AND THE PHYSICIAN THINKS IT MIGHT BE AN ALLERGY TO TEGADERM. THE PATIENT IS IMPROVING AND IS BEING SCHEDULED FOR A PERMANENT IMPLANT PROCEDURE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16142798 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED POST-OP PROCEDURAL PAIN AND SWELLING AND THEY ARE NOT GETTING PAIN RELIEF. THERAPY WAS NEVER ACHIEVED AND THE TRIAL WAS REMOVED ON (B)(6) 2022. THE SWELLING HAS DECREASED AND THE PATIENT IS DOING FINE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15973893 ↗
• InjurySep 16, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED AN INFECTION IN THEIR ANKLE AND LEG FOLLOWING A TRIAL. THE LEAD WAS REMOVED ON (B)(6) 2021. NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12485700 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem

  PATIENT WAS VERY SLEEPY COMING OUT OF ANESTHESIA POST PROCEDURE. PATIENT WAS LATER ADMITTED TO THE HOSPITAL AFTER A FALL, AND WAS THEN ADMITTED AGAIN DUE TO THE PATIENT HAVING A FEVER AND POTENTIAL INFECTION.

  Patient problems: Pneumonia; Urinary Tract Infection

  MAUDE report 12363524 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171366. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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
• 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-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