PULSAVAC® 00-5150-475-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 255 adverse event reports that list this exact device (DI 00889024375161), received between Apr 9, 2020 and Aug 27, 2026 — classified as 254 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (56 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 255 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Mechanical Problem

  It was reported that during surgery, the device did not work, even the motor at all. Batteries had leaked electrolyte inside of the pack was confirmed after the investigation was completed. There was no patient impact and there is no information if a delay occurred. Due diligence is complete as no additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50485639 ↗
• OtherAug 25, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439383 ↗
• MalfunctionJun 24, 2026Inability to Irrigate; Pressure Problem

  IT WAS REPORTED THAT DURING THE SURGERY, THIS COMPLAINT PRODUCT DIDN'T SPRAY SALINE WATER ALTHOUGH THE MOTOR WAS WORKING IN HIGH MODE. BUT, THIS COMPLAINT PRODUCT ABLE TO SPRAY SALINE WATER IN LOW MODE, SO THE SURGEON COMPLETED THE SURGERY USING THIS COMPLAINT PRODUCT IN LOW MODE ONLY. A 0-15 MINUTES DELAY OCCURRED, BECAUSE THE SURGEON FINISHED THE SURGERY USING THIS COMPLAINT PRODUCT IN LOW MODE ONLY. DURING DEVICE EVALUATION, BATTERY LEAKED ELECTROLYTE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25613055 ↗
• MalfunctionJun 24, 2026Overheating of Device; Activation Failure

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE FAILED TO FUNCTION AND BECAME HOT, AND A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE. DURING INTRA-OPERATIVE USE, THE MOTOR DID NOT OPERATE AND THE DEVICE HEATED UP. A BACKUP DEVICE WAS PREPARED AND USED, RESULTING IN APPROXIMATELY 0¿15 MINUTES OF SURGICAL DELAY. THE PATIENT HAD NO CONSEQUENCES OR IMPACT. DURING DEVICE EVALUATION, BATTERIES LEAKED ELECTROLYTE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612638 ↗
• MalfunctionJun 24, 2026Inability to Irrigate; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT DID NOT SPRAY SALINE WATER ALTHOUGH THE MOTOR WAS WORKING AND IT MADE AN ABNORMAL NOISE. BATTERY EXPULSION WAS CONFIRMED AFTER FINAL ASSESSMENT. THERE WAS NO PATIENT IMPACT OR A DELAY REPORTED. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610453 ↗
• MalfunctionJun 24, 2026Inability to Irrigate; Noise, Audible

  IT WAS REPORTED THAT DURING PREPARATION FOR THE SURGERY THE DEVICE DID NOT SPRAY SALINE WATER ALTHOUGH THE MOTOR WAS WORKING AND IT MADE AN ABNORMAL NOISE WHILE WORKING. INVESTIGATION FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25607079 ↗
• MalfunctionJun 19, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE FAILED TO POWER ON AND THE MOTOR DID NOT FUNCTION. SUBSEQUENTLY, EVALUATION FOUND THE DEVICE WOULD NOT POWER ON, AND VISUAL INSPECTION OF THE POWER PACK IDENTIFIED BATTERY ELECTROLYTE LEAKAGE WITHIN THE PACK. THERE WAS NO PATIENT HARM, AND IT IS UNKNOWN IF THERE WAS A DELAY. DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25560342 ↗
• MalfunctionMay 13, 2026Inability to Irrigate

  IT WAS REPORTED THAT DURING SURGERY, ON (B)(6) 2025, THE DEVICE DID NOT SPRAY. ANOTHER PRODUCT WAS USED FOR THE SURGERY. THERE WAS NO PATIENT IMPACT AND THERE WAS A DELAY OF 0-15 MIN. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162424 ↗
• MalfunctionMay 7, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY ON THE DEVICE DID NOT WORK. DURING INVESTIGATION IT WAS FOUND THAT 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 25110394 ↗
• MalfunctionApr 30, 2026Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043721 ↗
• MalfunctionApr 29, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE SURGERY, THIS COMPLAINT PRODUCT DIDN'T WORK AT ALL. NO SERIOUS INJURY, NO INFO ON DELAY. AT DEVICE EVALUATION IT WAS NOTED THAT THE BATTERY LEAKED ELECTROLYTE. DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035221 ↗
• MalfunctionApr 24, 2026Decrease in Pressure; Noise, Audible; Activation Problem

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT COULD NOT BE SWITCHED BETWEEN HIGH AND LOW MODE AND WATER PRESSURE WAS TOO LOW TO USE. ADDITIONALLY, THE UNIT MADE AN ABNORMAL NOISE DURING USE SO ANOTHER PRODUCT WAS USED INSTEAD. BATTERY LEAKING ELECTROLYTE WAS CONFIRMED AFTER FINAL ASSESSMENT. THERE WAS NO PATIENT IMPACT OR HARM AND THERE WAS A DELAY OF 0-15 MIN. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981432 ↗
• MalfunctionApr 23, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE PRODUCT DIDN'T WORK IN HIGH MODE. 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 3RD BATTERY FROM THE POWER PLUG OF THE PACK HAD LEAKED ELECTROLYTE. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971248 ↗
• MalfunctionApr 21, 2026Inability to Irrigate; Noise, Audible

  IT WAS REPORTED THAT DURING SURGERY THE UNIT DID NOT SPRAY SALINE WATER AND MADE AN ABNORMAL NOISE. AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT BUT THERE WAS A DELAY OF 0-15 MIN. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940232 ↗
• MalfunctionMar 31, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE DID NOT WORK. THERE WAS NO PATIENT INJURY, OR DELAY. AFTER INVESTIGATION VISUAL INSPECTION FOUND THAT BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746319 ↗
• MalfunctionFeb 27, 2026Unintended Power Up

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE STARTED WORKING INSIDE OF THE OUTER BOX DURING TRANSPORTATION. THERE WAS NO PATIENT IMPACT OR 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 24470682 ↗
• MalfunctionFeb 24, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE DID NOT WORK. THERE WAS NO PATIENT INJURY, OR DELAY. DURING 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 24431065 ↗
• MalfunctionFeb 23, 2026Battery Problem

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE DID NOT WORK AT ALL AND THE MOTOR WAS NOT WORKING EITHER. THE BATTERY PACK WAS REPLACED AND THE DEVICE STARTED TO WORK. THERE WAS NO PATIENT IMPACT BUT THERE WAS A 0-15 MINUTE DELAY WHILE THE BATTERY PACK WAS BEING REPLACED. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE BATTERY HAD LEAKED ELECTROLYTE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24417509 ↗
• MalfunctionFeb 23, 2026Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY PRODUCT DIDN'T WORK EVEN THE MOTOR FROM START AND BATTERY PACK WAS GETTING HOT. NO SERIOUS INJURY AND A 0-15 MINUTE DELAY WAS NOTED. UPON EVALUATION OF DEVICE AT INVESTIGATION IT WAS NOTED THAT THE BATTERIES HAD LEAKED ELECTROLYTE. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFO WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416554 ↗
• MalfunctionFeb 20, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY THE COMPLAINT PRODUCT DIDN'T WORK EVEN THE MOTOR AT ALL. THERE WAS NO PATIENT HARM. THERE WAS NO INFORMATION ON SURGICAL DELAY. DURING DEVICE EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFO WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400268 ↗
• MalfunctionFeb 20, 2026Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY THE PRODUCT DIDN'T WORK AT ALL. THE BATTERY PACK GOT VERY HOT. NO INFORMATION WAS PROVIDED ON HARM OR SURGICAL DELAY. DURING DEVICE EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFO WAS NOTED.

  Patient problems: Insufficient Information

  MAUDE report 24400263 ↗
• MalfunctionFeb 17, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE FOREIGN SUBSTANCE WAS FOUND INSIDE OF THE PACKAGE WHEN THE NURSE OPENED THE PACKAGE. THERE WAS NO PATIENT IMPACT. THERE WAS ABOUT 0-15 MINUTES DELAY IN SURGICAL PROCEDURE AS ANOTHER DEVICE HAS BEEN USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24361910 ↗
• MalfunctionFeb 9, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE HAD A FOREIGN SUBSTANCE WHICH LOOKED LIKE A WHITE POWDER ATTACHED ON THE TUBE INSIDE OF THE STERILE TRAY. THERE WAS NO PATIENT INJURY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291822 ↗
• MalfunctionJan 26, 2026Explosion

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE BATTERY PACK FOR THE PULSAVAC DEVICE EXPLODED WITHIN ITS PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182927 ↗
• MalfunctionJan 26, 2026Inability to Irrigate; Noise, Audible

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE DID NOT WORK AT ALL AS IT DID NOT SPRAY SALINE WATER ALTHOUGH THE MOTOR WAS WORKING. THERE WAS ALSO AN ABNORMAL SOUND. THERE WAS NO PATIENT IMPACT BUT THERE WAS A 0-15 MINUTE DELAY IN THE PROCEDURE WHILE AN ALTERNATE DEVICE WAS BEING PREPARED. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE BATTERIES LEAKED ELECTROLYTE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179882 ↗