VARI-STIM® 8562010 (UDI 20643169341818)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20643169341818), received between Apr 6, 2018 and Mar 5, 2020 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2020Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE DIDN'T WORK DURING PROCEDURE. PROCEDURE WAS COMPLETED USING A BACK-UP PRODUCT. PATIENT WAS ALIVE-NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9792212 ↗
• MalfunctionDec 9, 2019Device Sensing Problem; Device Sensing Problem

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT DURING NEUROLYSIS, HCP FOUND THAT THE DEVICE WAS LESS SENSITIVE WHEN DETECTING THE NERVE. AFTER SEVERAL TESTS, IT STILL DIDN'T IMPROVE. THERE WAS ABOUT 5 MINUTES DELAY. HCP USED ANOTHER ONE TO COMPLETE THE OPERATION. PATIENT ALIVE-NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9436689 ↗
• MalfunctionOct 2, 2019Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE NERVE LOCATOR DID NOT WORK. A SECOND ONE WAS OPENED WITH A DIFFERENT LOT NUMBER WHICH WORKED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145190 ↗
• MalfunctionApr 12, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE WORKED ONCE ON THE PATIENT, THEN HAD TO OPEN ANOTHER ONE BECAUSE IT DIDN'T WORK THE SECOND TIME. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8508932 ↗
• MalfunctionNov 27, 2018Unable to Obtain Readings; Use of Device Problem; Unable to Obtain Readings; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT ONE OF THE ITEM IN THE STIMULATOR PACK OF 10 WAS NOT WORKING. THEY WERE PERFORMING A NERVE REPAIR ON THE HAND. DURING THE PROCEDURE, THE STIMULATOR WAS OPENED, PRESSED BLACK BUTTON AND NOTHING HAPPENED. THEY TRIED TO TOUCHED ENDS TOGETHER AND STILL NOTHING HAPPENED. THEY TRIED TO TOUCH NERVE OF THE PATIENT AND STILL NOTHING HAPPENED. THERE WAS NO VISUAL/AUDIBLE INDICATORS AS WELL AS NO INDICATOR WHETHER THE CONNECTION WAS INTERMITTENT. THE STIMULATOR WAS USED FOR THE FIRST TIME. THEY READ THE INSTRUCTIONS/DIRECTIONS IN THE PACKAGE; HOWEVER, IT DIDN'T REALLY EXPLAIN WHAT TO DO. THEY OPENED ANOTHER PACKAGE AND STILL IT DID NOT WORK. THE CASE WAS CONTINUED; HOWEVER, THEY WERE UNABLE TO USE THE STIMULATOR TO CHECK NERVE ON THE PATIENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8107248 ↗
• MalfunctionNov 20, 2018Failure to Sense; Failure to Sense

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT A NERVE MONITORING DEVICE WAS NOT SENSING AND HAD NO LIGHT, DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8088682 ↗
• MalfunctionNov 13, 2018Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT ONE OF THE ITEM IN THE STIMULATOR PACK OF 10 WAS NOT WORKING. THEY WERE PERFORMING A NERVE REPAIR ON THE HAND. DURING THE PROCEDURE, THE STIMULATOR WAS OPENED, PRESSED BLACK BUTTON AND NOTHING HAPPENED. THEY TRIED TO TOUCH ENDS TOGETHER AND STILL NOTHING HAPPENED. THEY TRIED TO TOUCH NERVE OF THE PATIENT AND STILL NOTHING HAPPENED. THERE WAS NO VISUAL/AUDIBLE INDICATORS AS WELL AS NO INDICATOR WHETHER THE CONNECTION WAS INTERMITTENT. THE STIMULATOR WAS USED FOR THE FIRST TIME. THEY READ THE INSTRUCTIONS/DIRECTIONS IN THE PACKAGE; HOWEVER, IT DID NOT REALLY EXPLAIN WHAT TO DO. THEY OPENED ANOTHER PACKAGE AND STILL IT DID NOT WORK. THE CASE WAS CONTINUED; HOWEVER, THEY WERE UNABLE TO USE THE STIMULATOR TO CHECK NERVE ON THE PATIENT. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8065717 ↗
• MalfunctionNov 12, 2018Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE STIM WAS OPENED ON THE STERILE FIELD IN PREPARATION FOR USE DURING THE PROCEDURE, HOWEVER THE DEVICE DID NOT WORK WITH MULTIPLE ATTEMPTS. THERE WAS NO VISUAL OR AUDIBLE INDICATORS THAT ALERTED THE USER OF THE ISSUE. THERE WAS A MINOR DELAY WHILE OPENING THE UNIT; HOWEVER, THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE HCP OPENED ANOTHER ONE AND CONTINUED WITH THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8060654 ↗
• MalfunctionAug 24, 2018Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE VARISTIM DID NOT WORK. IT WAS THE INITIAL USE OF THE DEVICE. THE USER OPENED ANOTHER VARISTIM AND IT WORKED RIGHT AWAY. THERE WAS NO INJURY; NO PATIENT IMPACT OTHER THAN A SHORT DELAY TO OPEN ANOTHER PACKAGE OF VARISTIM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7812284 ↗
• MalfunctionApr 6, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT THE VARI-STIM III DID NOT STIMULATE WHEN TESTED, DESPITE THE BATTERY INDICATOR LIGHT COMING ON PRIOR TO USE. THE EVENT IS NOT ASSOCIATED WITH A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7405532 ↗