PULSAVAC® 00-5150-495-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024375215), received between Apr 16, 2024 and Jun 24, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Overheating of Device

  IT WAS REPORTED THAT DURING AN UNKNOWN TIMING, THE UNIT WAS GETTING VERY HOT AS WELL AS THE BATTERY PACK. BATTERY EXPULSION WAS CONFIRMED AFTER FINAL INVESTIGATION. IT IS UNKNOWN IF THERE WAS A PATIENT IMPACT OR IF A DELAY OCCURRED. DUE DILIGENCE IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 25608621 ↗
• MalfunctionApr 27, 2026Powder Leak

  IT WAS REPORTED THAT DURING SURGERY BATTERY LOOKS TO HAVE MALFUNCTIONED WITHIN THE PACKAGING. THERE WAS BLACK DEBRIS WITHIN THE PACKAGING. THE BATTERY PACK MAY HAVE EXPLODED. THERE WAS NO PATIENT IMPACT, NO DELAY, AND NO MEDICAL INTERVENTION. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008350 ↗
• MalfunctionFeb 20, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE WOULD NOT POWER ON AND HAD NO POWER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. AT INVESTIGATION IT WAS FOUND THAT BATTERIES HAD LEAKED ELECTROLYTE. DILIGENCE IS COMPLETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401053 ↗
• MalfunctionMar 25, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY ON THE PULSAVAC BATTERY PACK QUICKLY BECAME HOT. THERE WERE NO SIGNS OF DAMAGE OR LEAKAGE FROM BATTERY REPORTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SHORT DELAY IN PROCEDURE TO PREPARE THE ALTERNATE DEVICE. NO PATIENT HARM/IMPACT WAS REPORTED. DUE DILIGENCE INFORMATION IS COMPLETE. DURING DEVICE EVALUATION VISUAL INSPECTION OF THE INTERIOR OF THE PACK FOUND THE BATTERIES HAD LEAKED ELECTROLYTE INSIDE OF THE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687317 ↗
• MalfunctionOct 31, 2024Explosion; Powder Leak; Explosion; Powder Leak

  THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575672 ↗
• MalfunctionOct 18, 2024Overheating of Device; Expulsion; Overheating of Device; Expulsion

  DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482221 ↗
• MalfunctionSep 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171278 ↗
• MalfunctionAug 5, 2024Delivered as Unsterile Product; Battery Problem; Delivered as Unsterile Product; Battery Problem

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905653 ↗
• MalfunctionAug 5, 2024Delivered as Unsterile Product; Battery Problem; Explosion; Delivered as Unsterile Product; Battery Problem; Explosion

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905618 ↗
• MalfunctionMay 20, 2024Overheating of Device; Battery Problem; Device Contaminated During Manufacture or Shipping; Overheating of Device; Battery Problem; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350973 ↗
• MalfunctionMay 1, 2024Battery Problem; Device Contaminated During Manufacture or Shipping; Explosion; Battery Problem; Device Contaminated During Manufacture or Shipping; Explosion

  THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19224180 ↗
• MalfunctionApr 16, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  THERE IS NO ADDITIONAL EVENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121507 ↗