Cervical-STIM 5505Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 18257200105632), received between Aug 22, 2024 and Jun 26, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Insufficient Device Problem Information

  AS REPORTED THE PATIENT HAD A RASH ON THE LEFT SIDE OF THEIR CLAVICLE WHICH STARTED A MONTH AFTER USING THE DEVICE AND IS NOT GOING AWAY.

  Patient problems: Rash

  MAUDE report 25638796 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  MEDWATCH REPORT: MW585017 WAS RECEIVED 4/10/2026. PATIENT REPORTED DEVELOPING SEVERE NEURALGIA PAIN AND NUMBNESS IN LEFT SHOULDER, LEFT ARM TO HAND, WITH INCREASED WEAKNESS, AND INCREASED NUMBNESS IN RIGHT HAND AND PAIN IN NECK. PATIENT REPORTED IT TOOK ALMOST A WEEK FOR MOST SYMPTOMS TO RESOLVE AND STILL WAS SYMPTOMATIC FOR AN ADDITIONAL WEEK OR TWO. AFTER A FOLLOW UP CALL TO THE PATIENT WAS MADE ON (B)(6) 2026 PATIENT REPORTED FEELING NORMAL BUT HAS DISCONTINUED USE OF THE DEVICE.

  Patient problems: Muscle Weakness/Atrophy; Neck Pain; Numbness

  MAUDE report 25070486 ↗
• InjuryApr 6, 2026Insufficient Device Problem Information

  PATIENT REPORTED FALLING ASLEEP WITH THE DEVICE ON AND THE COLLAR SLIPPED UP AROUND THE JAW AREA FOR ABOUT ONE HOUR. UPON WAKING THE PATIENT REPORTED HEARING GOING OUT AND WATER/FLUID CAME OUT OF THE EAR. THE PATIENT WAS SEEN BY THE PRESCRIBING DOCTOR AND WAS PRESCRIBED MEDICATION. PATIENT DISCONTINUED USE OF THE DEVICE.

  Patient problems: Hearing Impairment

  MAUDE report 24792889 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED SHE DISCONTINUED USE DUE TO THE DEVICE RUBBING THE WOUND FROM HER PRIOR SURGERY ON HER NECK. PATIENT STATED SHE HAD TO HAVE ADDITIONAL SURGERY TO CLOSE THE WOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835174 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED HE WAS DEVELOPING BRADYCARDIC HEART RHYTHM AND EXPERIENCED LOSS OF CONSCIOUSNESS. PATIENT STATED HE HAS NO HISTORY OF SUCH SYMPTOMS. PATIENT SEEKED TREATMENT FOR BRADYCARDIC HEART RHYTHM AND HAS HAD A 3 VESSEL BYPASS.

  Patient problems: Bradycardia; Loss of consciousness

  MAUDE report 23835003 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THE DEVICE MADE HIS HEAD FEEL LIKE IT WAS ON FIRE. DURING A FOLLOW UP CALL THE PATIENT STATED THAT THE UNIT FELT HOT AND IT MADE HIS HEAD FEEL HOT. THE DEVICE HAS BEEN REQUESTD FOR RETURN.

  Patient problems: Burning Sensation

  MAUDE report 23769268 ↗
• InjurySep 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED AND REPORTED A BURNING SENSATION CAUSING THE TREATMENT AREA TO BLISTER. PATIENT STATED SHE SKIPPED A TREATMENT DAY AND FELT SOME RELIEF AND WHEN SHE STARTED TREATING AGAIN, SHE EXPERIENCED THE SIMILAR ISSUE.

  Patient problems: Blister

  MAUDE report 23064691 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT REPORTED FEELING ITCHING AND HAVING TWO BLISTERS ON THE BACK OF THE NECK. PATIENT TREATS FOR FOUR HOURS A DAY. NO ADDITIONAL INFORMATION HAD BEEN PROVIDED.

  Patient problems: Blister

  MAUDE report 22913337 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT CALLED AND REPORTED THAT THE DEVICE GOT HOT AND BURNED HER AND LEFT CUSHION MARKS ON THE BACK OF HER NECK. ON (B)(6) 2025 A FOLLOW UP PHONE CALL TO PATIENT. PATIENT STATED STARTED USING THE DEVICE ON MONDAY (B)(6). ON WEDNESDAY, (B)(6) PATIENT WAS OUTSIDE WEARING THE DEVICE ON NECK AND HAD AN UNCOMFORTABLE FEELING BUT DOES NOT REMEMBER THE DEVICE FEELING HOT OR WARM. PATIENT STATED AFTER TAKING OFF THE DEVICE, HUSBAND NOTICED BRUISING AND BLACK MARK ON AREA WHERE PATIENT WAS WEARING THE DEVICE. PATIENT STATED THE BLACK MARK SEEMED TO BE IN THE SHAPE OF THE DEVICE, AND WHERE DEVICE WAS SITTING ON NECK. PATIENT STATED DID NOT SEEK MEDICAL CARE OR GOING TO THE DOCTOR AFTER THIS OCCURRED. PATIENT STATED IT WAS AWKWARD IN GENERAL TO TURN WHEN WEARING THE DEVICE. PATIENT STATED IS NEXT MEETING WITH DOCTOR ON (B)(6). PATIENT STATED HAVE NOT NOTICED SYMPTOMS GETTING WORSE OR CHANGE TO AREA. PATIENT STATED BLACK MARK IS STILL CURRENTLY ON NECK AREA. PATIENT STATED STOPPED USING THE DEVICE LAST WEDNESDAY AFTER EVENT OCCURRED. PATIENT STATED THEY HAD REACHED OUT TO REP WHO HAD GIVEN THE DEVICE TO SIMPLY NOTIFY THIS HAD HAPPENED.

  Patient problems: Burn(s)

  MAUDE report 22194779 ↗
• InjuryMar 27, 2025Unintended Electrical Shock; Unintended Electrical Shock

  PATIENT CALLED AND REPORTED THAT SHE WAS RUSHED TO THE EMERGENCY ROOM. SHE WAS WEARING THE DEVICE AND STEPPED IN A PUDDLE AND STATED THE UNIT ELECTROCUTED HER BODY AND THERE WERE BURNS. PATIENT STATED THAT SHE LOST FUNCTIONALITY OF HER UPPER AND LOWER EXTREMITIES FOR A PERIOS OF TIME, BECAME DIZZY, DISORIENTED AND NAUSEOUS.

  Patient problems: Burn(s); Dizziness; Nausea

  MAUDE report 21712159 ↗
• InjuryMar 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT CALLED AND REPORTED THE DEVICE WAS BURNING HER SKIN. PATIENT STATED SHE TRIED USING A TOWEL FOR EXTRA LAYERS AND THE UNIT BURNED HER HAND TOUCHING IT. SHE IS ON HER NECK AND CHEST DURING AND AFTER TREATMENT AND UNABLE TO WEAR HER BRACE AND HAD ANAPHYLAXIX SHOCK.

  Patient problems: Burning Sensation

  MAUDE report 21677879 ↗
• InjuryNov 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT NOTICED BURNING/REDNESS AFTER REMOVING THE DEVICE ON (B)(6) 2024. PHONE CALL WAS MADE TO PATIENT ON (B)(6) 2024. PATIENT STATED THAT FOR ABOUT 4 DAYS SHE WOULD NOTICE IT WOULD GET WARM ON HER NECK AND SHE WOULD PUSH UNIT BACK. PATIENT STATED SHE THEN NOTICED NECK FEELING ITCHY AND TIGHT. PATIENT STATED AT THAT TIME HER HUSBAND LOOKED AT IT AND TOLD HER THERE WAS A BURN ON HER NECK. PATIENT REPORTED PEELING IN 1" X 2" STRIPS FOR TWO WEEKS. PATIENT STATED SHE CALLED THE PRESCRIBING PHYSICIAN AND WAS TOLD TO DISCONTINUE USE. PATIENT EXPRESSED CONCERN OVER POSSIBLE LONG-TERM EFFECTS. PATIENT HAS NOT RETURNED DEVICE AT THIS TIME.

  Patient problems: Burn(s)

  MAUDE report 20634238 ↗
• InjuryAug 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST TIGHTNESS FOLLOWED BY WARMNESS AND BURING DURING HIS 4TH TREATMENT. PATIENT SAID THE UNIT WAS HOT. PATIENT SAID THE LCD BURNED HIM THROUGH HIS T-SHIRT. PATIENT STATED HE WENT TO THE ER AND THE ER DOCTOR SAID HE RECEIVED A BRUISE OR 1ST DEGREE BURN.

  Patient problems: Burn(s)

  MAUDE report 20041071 ↗
• InjuryAug 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT STATES SHE BEGAN TREATING IN (B)(6) 2023 AFTER CERVICAL SURGERY. AFTER A FEW WEEKS PATIENT STATED SHE EXPERIENCED SPASMS ON THE LEFT SIDE OF HER FACE AND EAR. PATIENT SAID SHE WAS UNSURE HOW LONG SHE ACTUALLY TREATED BUT KNEW IT WAS AT LEAST ONE MONTH. PATIENT REPORTED HAVING BRAIN SURGERY IN (B)(6) 2023.

  Patient problems: Dyskinesia

  MAUDE report 20030579 ↗