PULSAVAC® 00-5150-475-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 00889024375154), received between Aug 7, 2020 and Sep 24, 2026 — classified as 1 injury, 163 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (50 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 164 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Mechanical Problem

  It was reported that during surgery, the unit was not working. After final investigation, battery expulsion was confirmed. There was no patient impact or delay reported. Due diligence is complete as no further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884525 ↗
• MalfunctionSep 24, 2026Mechanical Problem

  It was reported that during surgery, the unit was not working. There were several units sent over for the same issue. There was no patient impact or delay reported. Due diligence is complete as no further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883948 ↗
• MalfunctionAug 27, 2026Failure to Power Up

  It was reported that during surgery, the device did not spray and made an abnormal noise Battery expulsion was confirmed after final investigation was completed. There was no patient impact and a delay of unknown time occurred while looking for a second pulsavac to wash the operation site. Due diligence is complete as no additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50486482 ↗
• MalfunctionAug 25, 2026Failure to Power Up; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439132 ↗
• MalfunctionJul 27, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50005302 ↗
• MalfunctionJun 25, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE/MOTOR DID NOT WORK FROM THE START OF USE. DURING PRODUCT EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. THERE WAS NO PATIENT IMPACT, BUT IT IS UNKNOWN IF THERE WAS DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623497 ↗
• MalfunctionJun 12, 2026Inability to Irrigate

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE WATER IS UNABLE TO COME OUT OF THE UNIT. THERE WAS NO PATIENT INVOLVEMENT. DURING THE INVESTIGATION, IT WAS FOUND THAT THE BATTERIES INSIDE THE PACK HAD LEAKED ELECTROLYTE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486113 ↗
• MalfunctionJun 11, 2026Overheating of Device

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE HANDPIECE BECAME VERY HOT AFTER POWERING ON. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING DEVICE EVALUATION, THE BATTERIES WERE LEAKING ELECTROLYTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470683 ↗
• MalfunctionJun 11, 2026Failure to Power Up; Battery Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME THERE WAS NO POWER WHEN TRYING TO TURN ON. TRIED TO CHANGE THE BATTERY AND CHECKED IT; IT WORKED, SO BATTERY PROBLEM. THERE WAS NO PATIENT IMPACT AND NO DELAY. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE. DURING DEVICE EVALUATION, THE BATTERIES WERE LEAKING ELECTROLYTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470448 ↗
• MalfunctionMay 14, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY THE DEVICES DID NOT WORK. NO PATIENT IMPACT OR DEATH. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. IT WAS NOTED DURING FINAL INVESTIGATION THAT THE BATTERY LEAKED ELECTROLYTE. NO ADDITIONAL INFORMATION WAS NOTED AS A RESULT DILIGENCE IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 25175488 ↗
• MalfunctionMay 13, 2026Inability to Irrigate

  IT WAS REPORTED THAT PRIOR TO SURGERY, THE PV DIDN'T SPRAY. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. THE SURGEON USED ANOTHER PRODUCT. DURING DEVICE EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166075 ↗
• MalfunctionMay 5, 2026Inability to Irrigate; Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY, THE PULSE LAVAGE DIDN'T MOVE WATER THROUGH, EVEN OVERHEATING TO THE POINT OF NOT BEING ABLE TO TOUCH THE UNIT. NO DEBRIS FELL NOR LEFT IN PATIENT. THERE WAS NO PATIENT HARM/INJURY. THERE WAS NO SURGICAL DELAY. THERE WAS NO MEDICAL INTERVENTION. DURING DEVICE EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086533 ↗
• MalfunctionMay 4, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE SURGERY, THE FOREIGN SUBSTANCE WAS FOUND INSIDE OF THE STERILE TRAY. THERE WAS NO PATIENT HARM. THERE WAS A 0-15 MINUTES DELAY OCCURRED DUE TO THE PREPARATION OF A BACKUP PRODUCT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071189 ↗
• MalfunctionMay 4, 2026Packaging Problem

  IT WAS REPORTED THAT DURING THE SURGERY, THE FOREIGN SUBSTANCE WAS FOUND INSIDE OF THE STERILE TRAY. THERE WAS NO PATIENT HARM. THERE WAS A 0-15 MINUTES DELAY OCCURRED DUE TO THE PREPARATION OF A BACKUP PRODUCT. DUE DILIGENCE IS COMPLET, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071156 ↗
• MalfunctionMay 4, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE SURGERY, THE FOREIGN SUBSTANCE WAS FOUND INSIDE OF THE STERILE TRAY. THERE WAS NO PATIENT HARM. THERE WAS A 0-15 MINUTES DELAY OCCURRED DUE TO THE PREPARATION OF A BACKUP PRODUCT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071044 ↗
• MalfunctionMay 4, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE SURGERY, THE FOREIGN SUBSTANCE WAS FOUND INSIDE OF THE STERILE TRAY. THERE WAS NO PATIENT HARM. THERE WAS A 0-15 MINUTES DELAY OCCURRED DUE TO THE PREPARATION OF A BACKUP PRODUCT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071031 ↗
• MalfunctionMay 4, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE SURGERY, THE FOREIGN SUBSTANCE WAS FOUND INSIDE OF THE STERILE TRAY. THERE WAS NO PATIENT HARM. THERE WAS A 0-15 MINUTES DELAY OCCURRED DUE TO THE PREPARATION OF A BACKUP PRODUCT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070944 ↗
• MalfunctionMay 4, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE SURGERY, THE FOREIGN SUBSTANCE WAS FOUND INSIDE OF THE STERILE TRAY. THERE WAS NO PATIENT HARM. THERE WAS A 0-15 MINUTES DELAY OCCURRED DUE TO THE PREPARATION OF A BACKUP PRODUCT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070906 ↗
• MalfunctionMay 4, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE SURGERY, THE FOREIGN SUBSTANCE WAS FOUND INSIDE OF THE STERILE TRAY. THERE WAS NO PATIENT HARM. THERE WAS A 0-15 MINUTES DELAY OCCURRED DUE TO THE PREPARATION OF A BACKUP PRODUCT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070882 ↗
• MalfunctionApr 30, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE SURGERY, THIS COMPLAINT PRODUCT DIDN'T WORK EVEN THE MOTOR AT ALL. THEREFORE, THE SURGEON USED A BACK UP PRODUCT FOR THE SURGERY. THERE WAS NO PATIENT HARM. THERE WAS A 0-15 MINUTE SURGICAL DELAY DUE TO THE PREPARATION OF A BACKUP PRODUCT. DURING DEVICE EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE. DUE DILIGENCE IS COMPLETE; THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25047427 ↗
• MalfunctionApr 21, 2026Battery Problem; Activation Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BATTERY IS DEFECTIVE, SO IT CANNOT BE USED. THERE WAS NO PATIENT HARM. THERE WAS A 1-MINUTE DELAY AS A NEW PRODUCT HAD TO BE RETRIEVED FROM STORAGE AND CONNECTED. THERE WAS NO MEDICAL INTERVENTION. THE BATTERY DID NOT EXHIBIT EXPULSION, LEAKING ELECTROLYTE/ACID, EXPLODES, OR RUPTURES. THEY USED THE PRODUCT AS USUAL ¿ WITH A CONTINUOUS TRIGGER OPERATION AS ALWAYS. WHEN THEY USED THE SAME PRODUCT AFTERWARDS THE SAME WAY, THERE WERE NO PROBLEMS WITH IT. THE PULSAVAC WASN¿T EVEN WORKING, IT NEVER STARTED. DURING DEVICE EVALUATION AND VISUAL EXAMINATION, IT WAS DISCOVERED THAT THE INTERIOR HAD ELECTROLYTE LEAKED INSIDE THE PACK. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944946 ↗
• MalfunctionApr 20, 2026Explosion

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE BATTERY EXPLODED WHILE THE DEVICE WAS NOT IN USE. THE DEVICE HAD NOT BEEN OPENED. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925496 ↗
• MalfunctionMar 30, 2026Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2025, THE DEVICE DID NOT WORK AT ALL AND THE HANDPIECE AND BATTERY WERE GETTING HOT. THERE WAS NO PATIENT IMPACT BUT IT IS UNKNOWN IF THERE WAS A DELAY. AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE BATTERY LEAKED ELECTROLYTE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731442 ↗
• MalfunctionMar 26, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE HANDGUN APPEARED TO MALFUNCTION WHEN THE TRIGGER WAS PUSHED. DURING PRODUCT EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THAT THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698778 ↗
• MalfunctionMar 20, 2026Activation Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE WAS NOT RESPONDING AT ALL AFTER BEING TAKEN OUT FROM PACKAGING. THEY TRIED TO UNPLUG BATTERY AND PLUG IT BACK ALSO NO RESPOND. THE TRIGGER BOTH BUTTONS WERE ALSO NOT WORKING. THERE WAS NO PATIENT INJURY, OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648342 ↗