Freedom System AccessoriesRecalls & reported problems across all models
Curonix LLC · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls
- 0
We found 3 models of Freedom System Accessories by Curonix LLC in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2024 and Sep 24, 2026 — classified as 36 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (19 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Freedom System Accessories problems
Device problems
- Use of Device Problem19
- Adverse Event Without Identified Device or Use Problem12
- Defective Component6
- Detachment of Device or Device Component6
- Electrical /Electronic Property Problem2
- Circuit Failure1
- Manufacturing, Packaging or Shipping Problem1
- Moisture Damage1
Patient problems
- Burning Sensation17
- Shock from Patient Lead(s)6
- No Clinical Signs, Symptoms or Conditions5
- Blister4
- Electric Shock4
- Rash4
- Skin Inflammation/ Irritation4
- Burn(s)1
Freedom System Accessories models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Freedom System Accessories PDBT-915-2KStimulator, Spinal-Cord, Implanted (Pain Relief)34 reports
- Freedom System Accessories 00-52004Stimulator, Peripheral Nerve, Implanted (Pain Relief)4 reports
- Freedom System Accessories 00-52002Stimulator, Peripheral Nerve, Implanted (Pain Relief)3 reports
Recent Freedom System Accessories adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888692 ↗MalfunctionAug 3, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113077 ↗MalfunctionMay 28, 2026Defective Component
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WOULD NOT CHARGE DESPITE USING THE USB CHARGER AND CABLE PROVIDED TO RECHARGE THE TRANSMITTER. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY AND NO FURTHER ISSUES HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323354 ↗MalfunctionMay 14, 2026Use of Device Problem
THE PATIENT REPORTED THE TRANSMITTER ASSEMBLY EMITTED A BURNING SMELL AND GOT EXTREMELY HOT WHILE CHARGING. HOWEVER, THE OVERHEATING DID NOT CAUSE A BURNING SENSATION TO THE SKIN OR TISSUE DAMAGE AND THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION. THE PATIENT ALSO REPORTED THE DEVICE WOULD NO LONGER CHARGE. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175001 ↗MalfunctionMay 14, 2026Use of Device Problem
THE PATIENT REPORTED THE TRANSMITTER ASSEMBLY EMITTED A BURNING SMELL AND GOT EXTREMELY HOT WHILE CHARGING. HOWEVER, THE OVERHEATING DID NOT CAUSE A BURNING SENSATION TO THE SKIN OR TISSUE DAMAGE AND THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION. THE PATIENT ALSO REPORTED THE DEVICE WOULD NO LONGER CHARGE. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166910 ↗InjuryApr 14, 2026Defective Component; Detachment of Device or Device Component
THE PATIENT REPORTED REDNESS AND A RASH ON THEIR SKIN UNDER WHERE THE TRANSMITTER ASSEMBLY IS WORN. ADDITIONALLY, THE PATIENT REPORTED THEY FEEL WARMTH FROM THE TRANSMITTER ASSEMBLY AND A BURNING SENSATION TO THE SKIN. HOWEVER, THE BURNING SENSATION DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. AS OF (B)(6) 2026, THE RASH HAS RESOLVED COMPLETELY, THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY, AND THE PATIENT IS DOING WELL.
Patient problems: Burning Sensation; Rash
MAUDE report 24876799 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED REDNESS AND A RASH ON THEIR SKIN UNDER WHERE THE TRANSMITTER ASSEMBLY IS WORN. ADDITIONALLY, THE PATIENT REPORTED WARMTH FROM THE TRANSMITTER ASSEMBLY WHICH CAUSED A BURNING SENSATION TO THE SKIN. HOWEVER, THE BURNING SENSATION DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. AS OF (B)(6) 2026, THE RASH HAS RESOLVED COMPLETELY, THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY, AND THE PATIENT IS DOING WELL.
Patient problems: Rash; Skin Burning Sensation
MAUDE report 24794177 ↗InjuryMar 17, 2026Use of Device Problem
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WAS GETTING HOT AND CAUSED A BURNING SENSATION TO THE SKIN. TOPICAL OINTMENT WAS USED AND AS OF (B)(6) 2026, THE SKIN IS HEALING. ADDITIONALLY, THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY. THE PATIENT HAS A FOLLOW UP APPOINTMENT ON (B)(6) 2026. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Burning Sensation
MAUDE report 24618695 ↗InjuryMar 17, 2026Use of Device Problem
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WAS GETTING HOT AND CAUSED A BURNING SENSATION TO THE SKIN. TOPICAL OINTMENT WAS USED AND AS OF (B)(6) 2026, THE SKIN IS HEALING. ADDITIONALLY, THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY. THE PATIENT HAS A FOLLOW UP APPOINTMENT ON (B)(6) 2026. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Burning Sensation
MAUDE report 24618692 ↗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 20, 2026Use of Device Problem
THE PATIENT REPORTED A BURNING SENSATION AND A BLISTER ON THEIR SKIN UNDERNEATH THEIR TRANSMITTER ASSEMBLY. THE PATIENT HAS BEEN USING THEIR OTHER TRANSMITTER ASSEMBLY AND IS NOW WEARING THE WEARABLE OVER A SOCK. AS OF (B)(6) 2026, THE BLISTER HAS CLEARED UP AND THE PATIENT HAS NOT EXPERIENCED ANY ADDITIONAL BURNING SENSATIONS.
Patient problems: Blister; Burning Sensation
MAUDE report 24403208 ↗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 ↗InjuryDec 23, 2025Use of Device Problem; Use of Device Problem
THE PATIENT REPORTED BLISTERS AFTER USING THE DEVICE. THE PATIENT MET WITH IMPLANTING CLINICIAN, WHO STATED THE WOUND SEEMS TO BE SUPERFICIAL. AS OF (B)(6) 2025, THE BLISTERS HAVE NOT GONE. HOWEVER, MEDICAL INTERVENTION WAS NOT REQUIRED. THE COMMERCIAL TEAM MEMBER RECOMMENDED NOT WEARING THE DEVICE DIRECTLY ON THE SKIN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Blister
MAUDE report 23882829 ↗InjuryDec 22, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component
THE PATIENT REPORTED A BURNING SENSATION FROM THEIR TRANSMITTER ASSEMBLY. HOWEVER, THE BURNING SENSATION DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY.
Patient problems: Burning Sensation
MAUDE report 23873290 ↗InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY GETS HOT AND CAUSED A BURNING SENSATION TO THE SKIN. HOWEVER, THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION.
Patient problems: Burning Sensation
MAUDE report 23790567 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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