Stimulator, Nerve, Transcutaneous, For Pain Relief
FDA adverse event reports and recall history for stimulator, nerve, transcutaneous, for pain relief (product code GZJ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 500
- Deaths
- 4
- Injuries
- 289
- Malfunctions
- 91
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2012-04-19TerminatedPMA
Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO. Transcutaneous nerve stimulation for pain relief and other medical treatment uses.
Device was distributed without marketing approval.
- 2011-04-28TerminatedMaterial/Component Contamination
Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal Sport packaged with Triad alcohol wipes. The alcohol wipes manufactured by the Triad Group were labeled under brand names Triad, Select, Select Medical Products, PSS Select or PSS World Medical Inc. Alcohol wipe is provided as a cleaning convenience for device electrodes.
Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.
- 2007-09-01TerminatedOther
Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
- 2007-09-01TerminatedOther
Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
- 2007-09-01TerminatedOther
Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1; P/N #MB04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
- 2007-09-01TerminatedOther
Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
- 2003-06-17TerminatedOther
Line Powered RePak, Model Number 1785S
If there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse.
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