PULSAVAC® 00-5150-482-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00889024375192), received between Nov 23, 2020 and Jun 24, 2026 — classified as 154 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (36 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 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT DID NOT WORK AT ALL FROM THE START OF USE. BATTERY EXPULSION WAS CONFIRMED AFTER FINAL ASSESSMENT. THERE WAS NO PATIENT IMPACT AND IT IS UNKNOWN IF A DELAY OCCURRED. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25616113 ↗
• MalfunctionJun 24, 2026Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE DID NOT WORK EVEN THE MOTOR AT ALL, AND THE BATTERY PACK OF THIS COMPLAINT PRODUCT WAS GETTING HOT. INVESTIGATION FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. 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 25608824 ↗
• MalfunctionJun 18, 2026Battery Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BATTERY PACK OF THE UNIT WAS ALREADY DEFORMED WHEN THE NURSE OPENED THE PACKAGE. THERE WAS NO PATIENT IMPACT BUT IT IS UNKNOWN IF THERE WAS DELAY. DURING THE INVESTIGATION, IT WAS FOUND THAT 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 25549821 ↗
• MalfunctionJun 18, 2026Decrease in Pressure

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE HAD LOW POWER. THE POWER OF THE DEVICE WAS TOO LOW TO USE FROM START OF USE. THEREFORE ANOTHER PRODUCT WAS USED INSTEAD TO COMPLETETHE SURGERY. DURING FINAL ASSESSMENT BATTERY HAD LEAKED ELECTROLYTE. THERE WAS NO PATIENT IMPACT AND A DELAY OF 0-15MIN OCCURRED. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548711 ↗
• MalfunctionJun 3, 2026Leak/Splash

  IT WAS REPORTED THAT THE DEVICE DID NOT FUNCTION PRIOR TO SURGERY DUE TO BATTERY LEAKAGE. THE ISSUE WAS DISCOVERED BEFORE THE PROCEDURE, AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT. DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374614 ↗
• MalfunctionApr 27, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE SURGERY, THIS COMPLAINT PRODUCT DIDN'T WORK EVEN THE MOTOR AT ALL. NO SERIOUS INJURY. NO INFO ON DELAY. DURING FINAL INVESTIGATION IT WAS NOTED THAT THE INTERIOR OF THE ORIGINAL PACK FOUND THE BATTERIES LEAKED ELECTROLYTE INSIDE THE PACK DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000066 ↗
• MalfunctionApr 24, 2026Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY, THE BATTERY PACK WAS GETTING HOT, AND THE PRODUCT DID NOT WORK. DURING PRODUCT EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE ORIGINAL PACK FOUND THAT THE BATTERIES LEAKED ELECTROLYTE INSIDE THE PACK. THERE WAS NO PATIENT IMPACT, BUT IT IS UNKNOWN IF THERE WAS ANY DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982273 ↗
• MalfunctionApr 21, 2026Overheating of Device

  IT WAS REPORTED DURING THE SURGERY, THIS COMPLAINT PRODUCT DIDN'T WORK AT ALL FROM THE START OF USE, AND THE BATTERY PACK OF IT WAS GETTING VERY HOT. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY. DURING DEVICE EVALUATION AND VISUAL EXAMINATION OF THE INTERIOR OF THE PACK IT WAS DISCOVERED THAT THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941177 ↗
• MalfunctionMar 30, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE DID NOT WORK INCLUDING THE MOTOR. THERE WAS NO PATIENT IMPACT BUT THERE WAS A DELAY OF 0-15 MINUTES WHILE AN ALTERNATE DEVICE WAS BEING PREPARED. 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 24732526 ↗
• MalfunctionMar 26, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE DID NOT WORK AT ALL. THERE WAS NO PATIENT IMPACT BUT IT IS UNKNOWN IF THERE WAS ANY DELAY. 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 24702004 ↗
• MalfunctionMar 25, 2026Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY, THIS COMPLAINT PRODUCT DIDN'T WORK EVEN THE MOTOR AT ALL, AND THE BATTERY PACK OF THIS COMPLAINT PRODUCT WAS GETTING HOT. THERE WAS NO PATIENT HARM/INJURY. THERE WAS NO SURGICAL DELAY. DURING DEVICE EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690484 ↗
• MalfunctionMar 18, 2026Power Problem; Intermittent Loss of Power

  IT WAS REPORTED, DURING SURGERY, THE POWER IS TOO LOW TO USE AND IT KEPT MOVING AND STOPPING UNINTENTIONALLY. AN ALTERNATE PRODUCT WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT, BUT THERE WAS A DELAY OF 0-15 MINUTES WHILE THE BACKUP PRODUCT WAS BEING PREPARED. 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 24626827 ↗
• MalfunctionMar 18, 2026Battery Problem

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT WOULD NOT WORK AT ALL. THEREFORE, THE NURSE OPENED THE BACKUP OF THE SAME PRODUCT AND REPLACED THE BATTERY PACK OF THIS COMPLAINT PRODUCT TO NEW ONE ON TRIAL. THEN, THIS COMPLAINT PRODUCT BECAME TO WORK. DURING PRODUCT EVALUATION AND VISUAL INSPECTION, IT WAS FOUND THAT INSIDE THE PACK HAD ELECTROLYTE LEAKED. THERE WAS NO PATIENT/HARM INJURY REPORTED. THERE WAS A SURGICAL DELAY OF ABOUT 0-15 MINUTES DUE TO THE PREPARATION OF A BACKUP PRODUCT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626516 ↗
• MalfunctionMar 11, 2026Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY, THIS UNIT WOULD NOT WORK EVEN THE MOTOR AT ALL, AND THE PRODUCT WAS GETTING HOT. THEREFORE, THE SURGEON USED A BACKUP PRODUCT FOR THE SURGERY. THERE WAS NO PATIENT HARM/INJURY REPORTED. THERE WAS A SURGICAL DELAY OF ABOUT 0-15 MINUTES DUE TO THE PREPARATION OF A BACKUP PRODUCT. DURING THE INVESTIGATION, IT WAS FOUND THAT THE BATTERY HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570160 ↗
• MalfunctionFeb 26, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE DID NOT WORK AT ALL FROM THE BEGINNING. THERE WAS NO PATIENT IMPACT BUT IT IS UNKNOWN IF THERE WAS A DELAY. 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 24456295 ↗
• MalfunctionFeb 20, 2026Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT DIDN'T WORK EVEN THE MOTOR AT ALL, AND THE BATTERY PACK OF IT WAS GETTING HOT. THERE WAS NO PATIENT HARM/INJURY REPORTED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. DURING DEVICE EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400279 ↗
• MalfunctionFeb 19, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE SURGERY, THIS COMPLAINT DIDN'T WORK IN HIGH MODE. NO HARM NOTED. UPON COMPLETION OF DEVICE EVALUATION FOUND THE BATTERY HAD LEAKED ELECTROLYTE. NO ADDITIONAL INFO WAS NOTED. DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388826 ↗
• MalfunctionFeb 18, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE DID NOT WORK, EVEN THE MOTOR DID NOT WORK AT ALL FROM THE START OF USE. AN ALTERNATIVE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WAS A 0-15 MINUTE DELAY IN THE SURGERY WHILE THE BACKUP PRODUCT WAS PREPARED. THERE WAS NO PATIENT IMPACT. DURING PRODUCT EVALUATION IT WAS FOUND THAT 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 24381770 ↗
• MalfunctionJan 21, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT WOULD NOT WORK AT ALL (EVEN THE MOTOR). THERE WAS NO PATIENT HARM/INJURY REPORTED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. DURING DEVICE EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24140321 ↗
• MalfunctionDec 3, 2025Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THE UNIT WOULD NOT SPRAY BEFORE SURGERY. VISUAL INSPECTION OF THE BATTERY PACK SHOWED ELECTROLYTE LEAKING. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND THERE WAS NO DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708480 ↗
• MalfunctionNov 21, 2025Powder Leak; Powder Leak

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE BATTERIES OF THIS COMPLAINT PRODUCT HAS ALREADY BEEN EXPLODED INSIDE OF THE STERILE TRAY. THERE WAS NO PATIENT HARM. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618109 ↗
• MalfunctionNov 21, 2025Powder Leak; Powder Leak

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE BATTERIES OF THIS COMPLAINT PRODUCT HAS ALREADY BEEN EXPLODED INSIDE OF THE STERILE TRAY. THERE WAS NO PATIENT HARM. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618092 ↗
• MalfunctionNov 21, 2025Powder Leak; Powder Leak

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618086 ↗
• MalfunctionNov 20, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SURGERY THERE WAS WHITE POWDER ATTACHED ON THE PRODUCT INSIDE OF THE STERILE TRAY. 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 23609708 ↗
• MalfunctionNov 20, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SURGERY THERE WAS WHITE POWDER ATTACHED ON THE PRODUCT INSIDE OF THE STERILE TRAY. 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 23609698 ↗