PNS Freedom-4A Permanent Neurostimulator Receiver Kit Channel A FR4A-RCV-A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850051034291), received between Jun 16, 2025 and Jun 16, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Circuit Failure” (1 report).

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

• InjuryJun 16, 2025Circuit Failure; Use of Device Problem; Circuit Failure; Use of Device Problem

  THE PATIENT REPORTED DISCOMFORT FROM THE NEUROSTIMULATOR. ADDITIONALLY, THE PATIENT REPORTED AN INCREASED INCIDENCE OF INFECTIONS SINCE THEIR IMPLANT PROCEDURE (GANGRENOUS CHOLECYSTITIS WITH CHOLECYSTOLITHIASIS AND HERPES ZOSTER INFECTION V1-V3 WITH MUCOSAL INVOLVEMENT. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025. THE COMMERCIAL TEAM MEMBER WAS ABLE TO TEST THE NEUROSTIMULATOR AFTER THE EXPLANT PROCEDURE AND CONFIRMED THE BLUE LIGHT ILLUMINATED.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 22214816 ↗

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-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-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-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-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-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