PULSAVAC® 00-5150-420-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024375123), received between Aug 22, 2023 and Jun 13, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Battery 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Explosion; Powder Leak; Explosion; Powder Leak

  No further event information is available at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202672 ↗
• MalfunctionMay 30, 2025Explosion; Explosion

  IT WAS REPORTED THAT PRIOR TO SURGERY WHILE OPENING THE DELIVERY BOXES, THE PULSAVAC BATTERY HAD EXPLODED INSIDE THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120013 ↗
• MalfunctionApr 21, 2025Failure to Power Up; Material Deformation; Powder Leak; Failure to Power Up; Material Deformation; Powder Leak

  IT WAS REPORTED THAT DURING SURGERY, DID NOT TURN ON. WHEN THE BATTERY PACK WAS INSPECTED THERE WAS SOME DEFORMATION OF THE PLASTIC NOTED ON THE OUTSIDE. WHEN THE BATTERY PACK WAS OPENED FOR FURTHER INSPECTION, IT WAS DISCOVERED THAT 4 OF THE BATTERIES WERE CORRODED. 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 21874510 ↗
• MalfunctionApr 18, 2025Failure to Power Up; Material Deformation; Powder Leak; Failure to Power Up; Material Deformation; Powder Leak

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864394 ↗
• MalfunctionApr 1, 2025Expulsion; Explosion; Expulsion; Explosion

  IT WAS REPORTED THAT THERE WAS AN EXPLOSION INSIDE THE PACKAGING. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE IS NO HARM OR DELAY REPORTED. THE PACKAGE WAS NOT OPENED. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21745502 ↗
• MalfunctionMar 17, 2025Corroded; Leak/Splash; Explosion; Corroded; Leak/Splash; Explosion

  IT WAS REPORTED THAT THE PULSAVAC DID NOT FUNCTION, OPENED THE BATTERY PACK TO FIND CORROSION ON BATTERIES. PER THE IMAGE THE FIFTH BATTERY FROM THE RIGHT LEAKED ELECTROLYTE. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619244 ↗
• MalfunctionFeb 21, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING SURGERY THE PULSAVAC DEVICE WOULD POWER ON BUT WOULD NOT WORK. THE BATTERY WAS REPLACED BUT STILL WOULD NOT WORK. THERE WAS NO REPORT OF HARM OR DELAY. DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING DEVICE EVALUATION VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432345 ↗
• MalfunctionFeb 10, 2025Explosion; Explosion

  IT WAS REPORTED THAT BEFORE SURGERY, THE BATTERIES EXPLODED INSIDE PULSAVAC BOX. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344494 ↗
• MalfunctionFeb 10, 2025Explosion; Explosion

  IT WAS REPORTED THAT BEFORE SURGERY, THE BATTERIES EXPLODED INSIDE PULSAVAC BOX. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344410 ↗
• MalfunctionFeb 20, 2024Battery Problem; Device Contaminated During Manufacture or Shipping; Battery Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE BATTERY EXPLODED SO HE COULDN'T USE IT. THE EVENT OCCURRED DURING SURGERY .THERE WAS NO REPORTED PATIENT HARM, OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740020 ↗
• MalfunctionDec 6, 2023Failure to Power Up; Battery Problem; Failure to Power Up; Battery Problem

  IT WAS REPORTED THAT AT THE BEGINNING OF SURGERY THE BATTERIES IN SYSTEM WERE CORRODED, AND THE DEVICE DID NOT WORK. THE DEVICE WOULD NOT TURN ON. NO IMPACT, HARM, OR DELAY WERE REPORTED. DUE DILIGENCE INFORMATION IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277957 ↗
• MalfunctionNov 6, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING SURGERY THE BATTERY WAS LEAKING ACID UPON OPENING. THERE WAS NO PATIENT HARM AND NO DELAY NOTED. AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS IN PROCESS 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 18074151 ↗
• MalfunctionNov 6, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING SURGERY THE BATTERY WAS LEAKING ACID UPON OPENING. THERE WAS NO PATIENT HARM AND NO DELAY NOTED. AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS IN PROCESS 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 18074144 ↗
• MalfunctionNov 6, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING SURGERY THE BATTERY WAS LEAKING ACID UPON OPENING. THERE WAS NO PATIENT HARM AND NO DELAY NOTED. AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074136 ↗
• MalfunctionNov 6, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING SURGERY THE BATTERY WAS LEAKING ACID UPON OPENING. THERE WAS NO PATIENT HARM AND NO DELAY NOTED. AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS IN PROCESS 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 18074114 ↗
• MalfunctionAug 22, 2023Battery Problem; Manufacturing, Packaging or Shipping Problem; Battery Problem; Manufacturing, Packaging or Shipping Problem

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597192 ↗