VARI-STIMRecalls & reported problems across all models

We found 2 models of VARI-STIM by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2018 and Apr 16, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (22 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

Most reported VARI-STIM problems

VARI-STIM models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Vari-Stim® 8562010

  STIMULATOR, NERVE
  31 reports
• VARI-STIM® 8562010

  STIMULATOR, NERVE
  10 reports

Recent VARI-STIM adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Medtronic Xomed, Inc. products

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