Vari-Stim® 8562010 (UDI 20763000038315)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 20763000038315), received between Sep 27, 2019 and Apr 16, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (15 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, 3 UNITS OF THE SAME BATCH DID NOT OPERATE SUCCESSIVELY. THEY CONTINUED THE PROCEDURE WITHOUT USING THE VARI-STIM. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED THAT USER WAS NOT ABLE TO TRY TO INCREASE THE INTENSITY OF THE STIMULATION TO SEE IF IT CHANGED SOME THING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24892911 ↗
• MalfunctionJan 26, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PROCEDURE, (B)(4) UNITS OF THE SAME BATCH DID NOT OPERATE SUCCESSIVELY. THEY CONTINUED THE PROCEDURE WITHOUT USING THE VARI-STIM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186141 ↗
• MalfunctionDec 12, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT INTRA OP, THE VARI-STIM DID NOT GIVE A SIGNAL WHEN THE DOCTOR TOUCHED A NERVE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787726 ↗
• MalfunctionDec 12, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT INTRA OP, THE VARI-STIM DID NOT GIVE A SIGNAL WHEN THE DOCTOR TOUCHED A NERVE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787723 ↗
• MalfunctionJul 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SURGERY, NERVE STIM WORKED FOR THE FIRST 5 MINS OF CASE THEN STOPPED. NEW STIM WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22640028 ↗
• MalfunctionJul 24, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT IT WAS REPORTED THAT DURING INTRA-OPERATIVE, USER REPORTED OUT OF 10 PACK, 3 PACK WAS LIKE THEY WERE DEAD. THE LIGHT TURNED ON TOUCHING THE PROBE TIP, BUT NOT EVEN A TWITCH WHEN STIMULATING MUSCLE FIBERS DIRECTLY. THEY WERE QUITE STIFF TO TRY TO MOVE TO HIGHER VOLTAGE BUT EVEN AT MAX VOLTAGE THERE WAS ZERO TWITCH. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584909 ↗
• MalfunctionMar 14, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT PRIOR TO PROCEDURE, THE VARISTIM STIMULATOR WAS NON FUNCTIONAL, THE DEVICE COULD NOT WORK. THE DEVICE HAS NOT PASSED THE TEST BY ILLUMINATING THE LED LIGHT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607048 ↗
• MalfunctionFeb 26, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE VARI-STIM DID NOT WORK DURING SURGERY. DESPITE TURNING ON THE LIGHT, IT DID NOT GENERATE STIMULUS. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466902 ↗
• MalfunctionSep 30, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT INTRA-OPERATIVELY, WHEN THE SURGEON WENT TO USE THE DEVICE IT GAVE NO STIMULATION TO THE PATIENT AND THEY WERE UNABLE TO STIMULATE ANY OF THE NERVES THEY WERE TARGETING OR OTHERS NEAR BY. THE DEVICE WAS REMOVED AND THE SETTINGS WERE ADJUSTED ON THE END TWICE, AND IT STILL DID NOT ALLOW FOR STIMULATION. THE ISSUE WAS NOT RESOLVED WITH REPOSITIONING OR TROUBLESHOOTING. NEW ONE WAS OPENED FROM SAME LOT AND EXPIRY DATE WHICH WORKED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20331013 ↗
• MalfunctionAug 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING INTRA-OP, WHILE UNDERGOING A THYROIDECTOMY PROCEDURE ON RECURRENT LARYNGEAL NERVE, 2 BRAND NEW NERVE STIMULATORS (DESCRIBED ABOVE) WERE OPENED AND TRIED ON PATIENT. NONE OF THEM FUNCTIONED AS INTENDED. THE DOCTOR TRIED USING THEM ON PATIENT MUSCLES WITH NO RESULTS. THE THRESHOLD WAS SET TO 2 MA. THE PROBE TIP WAS TOUCHED TO THE NEEDLE ELECTRODE TO VERIFY FUNCTIONALITY. THERE WAS NO NOTICEABLE DAMAGE ON THE PRODUCT OR ITS PACKAGE. NEEDLE ELECTRODE WAS READJUSTED ON THE PATIENT. THE DOCTOR PROCEEDED WITH A THIRD PRODUCT OF THE SAME LOT NUMBER AND IT WORKED. THE PROBE WAS NOT TESTED WITH ANY OTHER NIM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19904371 ↗
• MalfunctionAug 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING INTRA-OP, WHILE UNDERGOING A THYROIDECTOMY PROCEDURE ON RECURRENT LARYNGEAL NERVE, 2 BRAND NEW NERVE STIMULATORS (DESCRIBED ABOVE) WERE OPENED AND TRIED ON PATIENT. NONE OF THEM FUNCTIONED AS INTENDED. THE DOCTOR TRIED USING THEM ON PATIENT MUSCLES WITH NO RESULTS. THE THRESHOLD WAS SET TO 2 MA. THE PROBE TIP WAS TOUCHED TO THE NEEDLE ELECTRODE TO VERIFY FUNCTIONALITY. THERE WAS NO NOTICEABLE DAMAGE ON THE PRODUCT OR ITS PACKAGE. NEEDLE ELECTRODE WAS READJUSTED ON THE PATIENT. THE DOCTOR PROCEEDED WITH A THIRD PRODUCT OF THE SAME LOT NUMBER AND IT WORKED. THE PROBE WAS NOT TESTED WITH ANY OTHER NIM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19904356 ↗
• MalfunctionJun 27, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING GENERAL SURGERY, VARI-STIM IS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCT. THERE WAS A DELAY TO PROCEDURE AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621631 ↗
• MalfunctionOct 5, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE VARI-STIM WERE DEFECTIVE AND NOT WORKING DURING THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17874667 ↗
• MalfunctionAug 7, 2023Sensing Intermittently; Sensing Intermittently

  IT WAS REPORTED THAT DURING PROCEDURE VARISTIM WORKED INTERMITTENTLY. THERE WAS NO VISUAL OR AUDIBLE INDICATORS AND NO ERROR CODES DISPLAYED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468826 ↗
• MalfunctionMay 18, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING PROCEDURE, PRODUCT DID NOT WORK. THERE WAS NO SIGNAL. NOTHING HAPPENED. THE PROCEDURE WAS COMPLETED WITH A BACKUP PRODUCT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952211 ↗
• MalfunctionMay 17, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE STIMULATOR DID NOT WORK. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16944267 ↗
• MalfunctionSep 22, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING NECK DISSECTION SURGERY FIVE VARI-STIMS OF SAME LOT WOULD NOT STIMULATE ON NERVES THAT THE SURGEON KNEW WERE NERVES. WHEN THEY OPENED A NEW LOT NUMBER, THE NERVES STIMULATED. NO APPARENT HARM OR PATIENT IMPACT. REACHED PATIENT/PERSON, INCONVENIENT AND THIS PROBLEM IS REOCCURRING. ON FOLLOW-UP THE INFORMATION SUGGESTS THAT NO MUSCLE RELAXANT WAS USED AT THAT TIME. THE STIM'S LIGHT TURNED ON WHEN THE ELECTRODE TOUCHED THE STIMULATOR SO IT INDICATED THAT IT WAS WORKING AND THERE WAS NO TONE SOUND. THE BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463761 ↗
• MalfunctionSep 22, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING NECK DISSECTION SURGERY FIVE VARI-STIMS OF SAME LOT WOULD NOT STIMULATE ON NERVES THAT THE SURGEON KNEW WERE NERVES. WHEN THEY OPENED A NEW LOT NUMBER, THE NERVES STIMULATED. NO APPARENT HARM OR PATIENT IMPACT. REACHED PATIENT/PERSON, INCONVENIENT AND THIS PROBLEM IS REOCCURRING. ON FOLLOW-UP THE INFORMATION SUGGESTS THAT NO MUSCLE RELAXANT WAS USED AT THAT TIME. THE STIM'S LIGHT TURNED ON WHEN THE ELECTRODE TOUCHED THE STIMULATOR SO IT INDICATED THAT IT WAS WORKING AND THERE WAS NO TONE SOUND. THE BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463616 ↗
• MalfunctionSep 22, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING NECK DISSECTION SURGERY FIVE VARI-STIMS OF SAME LOT WOULD NOT STIMULATE ON NERVES THAT THE SURGEON KNEW WERE NERVES. WHEN THEY OPENED A NEW LOT NUMBER, THE NERVES STIMULATED. NO APPARENT HARM OR PATIENT IMPACT. REACHED PATIENT/PERSON, INCONVENIENT AND THIS PROBLEM IS REOCCURRING. ON FOLLOW-UP THE INFORMATION SUGGESTS THAT NO MUSCLE RELAXANT WAS USED AT THAT TIME. THE STIM'S LIGHT TURNED ON WHEN THE ELECTRODE TOUCHED THE STIMULATOR SO IT INDICATED THAT IT WAS WORKING AND THERE WAS NO TONE SOUND. THE BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463140 ↗
• MalfunctionSep 22, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING NECK DISSECTION SURGERY FIVE VARI-STIMS OF SAME LOT WOULD NOT STIMULATE ON NERVES THAT THE SURGEON KNEW WERE NERVES. WHEN THEY OPENED A NEW LOT NUMBER, THE NERVES STIMULATED. NO APPARENT HARM OR PATIENT IMPACT. REACHED PATIENT/PERSON, INCONVENIENT AND THIS PROBLEM IS REOCCURRING. ON FOLLOW-UP THE INFORMATION SUGGESTS THAT NO MUSCLE RELAXANT WAS USED AT THAT TIME. THE STIM'S LIGHT TURNED ON WHEN THE ELECTRODE TOUCHED THE STIMULATOR SO IT INDICATED THAT IT WAS WORKING AND THERE WAS NO TONE SOUND. THE BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463070 ↗
• MalfunctionSep 8, 2022Use of Device Problem; Battery Problem; Use of Device Problem; Battery Problem

  IT WAS REPORTED THAT STIMULATOR NOT WORKING. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15377049 ↗
• MalfunctionAug 16, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THESE VARI-STIMS OF SAME LOT WOULD NOT STIMULATE ON NERVES THAT THE SURGEON KNEW WERE NERVES. WHEN THEY OPENED A NEW LOT NUMBER, THE NERVES STIMULATED. NO APPARENT HARM OR PATIENT IMPACT BUT REACHED PATIENT/PERSON, INCONVENIENT. THIS PROBLEM IS REOCCURRING. FOLLOW-UP INFORMATION SUGGESTS THAT NO MUSCLE RELAXANT WAS USED AT THAT TIME. THE STIM'S LIGHT TURNED ON WHEN THE ELECTRODE TOUCHED THE STIMULATOR SO IT INDICATED THAT IT WAS WORKING AND THERE WAS NO TONE SOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237147 ↗
• MalfunctionAug 26, 2021Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE VARISTIM DID NOT FUNCTION PROPERLY WHEN USE IN A CASE. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374161 ↗
• MalfunctionAug 26, 2021Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THE DEVICE DID NOT ACTIVATE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374151 ↗
• MalfunctionAug 26, 2021Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THE FIRST 3 DEVICE THEY TRIED AND DIDN¿T WORK. THE 4TH ONE THEY OPENED WORKED AND WAS USED IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374123 ↗