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

Summary

The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 00889024375185), received between Aug 19, 2020 and Sep 30, 2026 — classified as 197 malfunctions.

The most frequently reported specific device problem is “Inability to Irrigate” (67 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 197 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Inability to Irrigate

  It was reported that during surgery brand new device did not spray water. Investigation results found the batteries had leaked electrolyte inside of the pack. There was no patient impact. Due diligence is complete.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947778 ↗
• MalfunctionSep 25, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903924 ↗
• MalfunctionAug 27, 2026Inability to Irrigate; Overheating of Device

  It was reported that during surgery the device was not spraying and the battery was overheating. There was no patient impact or delay. During product evaluation it was found that the device leaked electrolyte. Due diligence is complete and there is no additional information available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50485193 ↗
• MalfunctionAug 21, 2026Failure to Power Up

  It was reported that during surgery the pulsavac won't turn on/respond. Investigation results found the batteries had leaked electrolyte inside of the pack. There was no patient harm. There was no medical intervention. There was no surgical delay. Due diligence is complete, there is no additional information available,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50371267 ↗
• MalfunctionJul 28, 2026Inability to Irrigate

  It was reported that during surgery, the unit malfunctioned. It was not spraying water from the device. Battery expulsion was confirmed after final assessment. There was no patient impact or delay. Due diligence is complete as no further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058749 ↗
• MalfunctionJun 24, 2026Inability to Irrigate

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE DOES NOT WORK PROPERLY, NO WATER SPRAYED OUT. THERE WAS NO PATIENT HARM OR DELAY. THE DEVICE WAS USED ON A CONTINUOUS TRIGGER OPERATION. THE UNIT RAN FOR 15 SECONDS. THE LOCATION OF THE SALINE BAG WAS ABOVE THE PATIENT. THERE WAS NO MEDICAL INTERVENTION. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. IT WAS DISCOVERED THAT DURING DEVICE EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND ELECTROLYTE LEAKED INSIDE. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610498 ↗
• MalfunctionApr 28, 2026Inability to Irrigate; Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT COULD NOT SPRAY, AND THE HANDPIECE WAS OVERHEATING. DURING PRODUCT EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK, IT WAS FOUND ELECTROLYTE LEAKED INSIDE OF THE PACK. THERE WAS NO PATIENT IMPACT AND THERE WAS A DELAY OF 5 MIN. DUE DILIGENCE IS COMPLETE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015233 ↗
• MalfunctionApr 21, 2026Inability to Irrigate; Failure to Power Up

  IT WAS REPORTED DURING THE SURGERY, THERE WAS NO WATER SPRAYED OUT FROM THE DEVICE DURING THE SURGERY. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY. AFTER REMOVING THE PACKAGE, THE DEVICE CAN`T TURN ON. THERE WAS NO MEDICAL INTERVENTION REQUIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. 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 24941174 ↗
• MalfunctionApr 8, 2026Inability to Irrigate

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE IS NOT WORKING AND IT SEEMS LIKE A BATTERY FAILURE. THE DEVICE WAS ABLE TO POWER ON BUT IT DID NOT SPRAY. THERE WAS A 5-MINUTE DELAY BUT THERE WAS NO HARM TO THE PATIENT. 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 24816451 ↗
• MalfunctionApr 7, 2026Inability to Irrigate

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT DID NOT WORK PROPERLY. NO WATER CAME OUT FROM THE DEVICE. BATTERY EXPULSION WAS CONFIRMED AFTER FINAL ASSESSMENT. THERE WAS NO PATIENT IMPACT AND THERE WAS A DELAY OF 20 MIN FOR A NEW DEVICE. ANOTHER DEVICE WAS USED INSTEAD. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809689 ↗
• MalfunctionMar 31, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT COULD NOT OPERATE PROPERLY, UNIT HAD NO POWER. BATTERY EXPULSION WAS CONFIRMED AFTER FINAL ASSESSMENT. THERE WAS NO PATIENT HARM OR IMPACT. THERE WAS A DELAY OF 5 MIN. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746905 ↗
• MalfunctionMar 31, 2026Inability to Irrigate

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE DID NOT SPRAY. THERE WAS NO PATIENT INJURY, OR DELAY, THERE WAS A DELAY OF 20 MINUTES. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. AFTER INVESTIGATION IT WAS FOUND THAT ELECTROLYTE LEAKED INSIDE OF THE PACK. DUE DILIGENCE IS COMPLETED AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745067 ↗
• MalfunctionMar 31, 2026Inability to Irrigate

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT WAS NOT WORKING PROPERLY, IT WOULD NOT SPRAY WATER OUT. DURING PRODUCT EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND ELECTROLYTE LEAKED INSIDE OF THE PACK. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY REPORTED. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742071 ↗
• MalfunctionMar 26, 2026Inability to Irrigate

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE DOES NOT WORK PROPERLY AND THERE WAS NO WATER COMING OUT OF THE DEVICE. THERE WAS A 20-MINUTE DELAY IN THE PROCEDURE WHILE AN ALTERNATE DEVICE WAS BEING PREPARED. THE SALINE BAG WAS ABOVE THE PATIENT. DESTRUCTIVE TESTING IS PERMITTED. THE MODE OF OPERATION CANNOT BE VERIFIED. THE DEVICE WAS OPERATED WITH A CONTINUOUS TRIGGER OPERATION. THE DEVICE WAS RUN IN THE FIELD FOR 30 SECONDS. THERE WAS NO PATIENT IMPACT. DURING THE INVESTIGATION, IT WAS FOUND THAT THE BATTERY ELECTROLYTE LEAKED INSIDE THE PACK. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703778 ↗
• MalfunctionMar 25, 2026Inability to Irrigate

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT WOULD NOT WORK PROPERLY AS NO WATER CAME OUT FROM THE DEVICE. THERE WAS A SURGICAL DELAY OF 20 MINUTES FOR AWAITING A NEW DEVICE. THERE WAS NO PATIENT HARM/INJURY REPORTED. THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED. THE SALINE BAG WAS LOCATED ABOVE THE PATIENT. THE UNIT WAS OPERATED WITH A CONTINUOUS TRIGGER OPERATION FOR 30 SECONDS. DURING THE INVESTIGATION, IT WAS FOUND THAT THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE THE PACK. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689022 ↗
• MalfunctionMar 19, 2026Inability to Irrigate

  IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE HANDGUN NORMAL SALINE COULD NOT SPOUT OUT WHEN THE TRIGGER WAS PRESSED. SUBSEQUENT EVALUATION FOUND THE DEVICE WOULD NOT POWER ON WITH THE ORIGINAL BATTERY PACK BUT POWERED ON AND FUNCTIONED NORMALLY WITH A LABORATORY BATTERY PACK. INSPECTION OF THE BATTERY PACK REVEALED ELECTROLYTE LEAKAGE INSIDE THE PACK WITH BATTERIES INSTALLED IN THE CORRECT ORIENTATION AND NO APPARENT WIRING DAMAGE. NO SURGICAL DELAY WAS REPORTED. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639424 ↗
• MalfunctionMar 3, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE STOPPED WORKING 10 SECONDS AFTER BEING USED. THERE WAS NO PATIENT IMPACT OR DELAY IN 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 24498323 ↗
• MalfunctionFeb 25, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING THE SURGERY, THE DEVICE CAN`T OPERATE PROPERLY. THE UNIT HAD NO POWER. THERE WAS A FIVE-MINUTE SURGICAL DELAY. THERE WAS NO PATIENT HARM. THERE WAS NO MEDICAL INTERVENTION REQUIRED. ANOTHER DEVICE WAS USED TO COMPLETE/FINISH THE SURGERY. DURING DEVICE EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND ELECTROLYTE LEAKED INSIDE OF THE PACK. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445110 ↗
• MalfunctionFeb 19, 2026Failure to Power Up

  IT WAS REPORTED THAT BEFORE OPERATION THERE WAS NO POWER TO TURN ON. THERE WAS NO PATIENT INVOLVED. DUE DILIGENCE IS COMPLETE. INVESTIGATION FOUND THAT THE ELECTROLYTE LEAKED INSIDE OF THE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393488 ↗
• MalfunctionJan 30, 2026Explosion

  IT WAS REPORTED THAT DURING SURGERY, BLACK PARTICLES WERE DETECTED IN TUBE OF THIS UNIT. THERE WAS NO PATIENT IMPACT OR DELAY REPORTED. DEBRIS WAS CONFIRMED AFTER FINAL ASSESSMENT. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222387 ↗
• MalfunctionJan 29, 2026Activation Problem

  IT WAS REPORTED THAT DURING INITIAL SURGERY THE HANDGUN APPEARED TO NOT FUNCTION WHILE PUSHING THE TRIGGER. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY REPORTED. THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE DEVICE LEAKED ELECTROLYTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210902 ↗
• MalfunctionJan 28, 2026Inability to Irrigate

  IT WAS REPORTED THAT DURING SURGERY THE UNIT WAS NOT FUNCTIONING AT ALL. THE UNIT HAD NO SOUND AND WAS NOT SPRAYING FOR BOTH MODES. THE DEVICE WAS NOT FUNCTIONING RIGHT FROM THE BEGINNING. IT CAN'T BE USE AT ALL FOR SURGERY. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. ANOTHER NEW ZIMMER PULSAVAC LAVAGE FROM THE SAME BATCH WAS USED TO COMPLETE THE SURGERY. THERE WAS A SURGICAL DELAY OF ABOUT 5 MINUTES WHILE THE GRABBED A NEW UNIT AND SET IT UP. THE PATIENT WAS UNDER ANESTHESIA. DURING DEVICE EVALUATION AND VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE BATTERY PACK. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201209 ↗
• MalfunctionDec 10, 2025Corroded; Failure to Power Up; Corroded; Failure to Power Up

  IT WAS REPORTED THAT DURING THE SURGERY, THE DEVICE COULD NOT BE TURN ON AND THE METAL PLATE IN BATTERY BOX APPEARS TO BE OXIDIZED. THERE WAS NO PATIENT INJURY, AND THERE WAS A 15 MINUTES DELAY. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. AFTER INVESTIGATION BATTERY EXPULSION/RUPTURE WAS FOUND. DUE DILIGENCE IS COMPLETED AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770140 ↗
• MalfunctionNov 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE WAS OPENED AND FOUND TO HAVE A SEVERELY MIS-SHAPED BATTERY PACK. THERE WAS NO PATIENT INJURY, OR DELAY. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. AFTER INVESTIGATION A BATTERY EXPULSION/RUPTURE DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645749 ↗
• MalfunctionNov 24, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME, AFTER OPENING, THE BLOCK NURSE COULD NOT TURN ON THE PULSAVAC. THEY OPENED A SECOND FUNCTIONAL KIT. DURING FINAL INSPECTION IT WAS NOTED BY VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. THERE WAS NO INFORMATION AVAILABLE REGARDING THE PATIENT IMPACT. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23635267 ↗