PULSAVAC® 00-5150-350-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024375031), received between Mar 13, 2023 and Jan 13, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Fluid/Blood Leak; Overheating of Device; Smoking; Fluid/Blood Leak; Overheating of Device; Smoking

  IT WAS REPORTED THAT JUST BEFORE CHECK-IN TO THE OPERATING ROOM, THE UNIT WAS CONNECTED AND THERE WAS HEAVY SMOKE DEVELOPMENT FROM THIS MOTOR UNIT. A CONDENSER (PURPLE-BROWN LARGE CYLINDER) HAD "BOILED" OR "BURNED". IN THE CHASSIS IT COULD BE SEEN THE FLUID THAT HAD COME OUT OF THE COMPONENT. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS IN PROCESS, NO FURTHER INFORMATION IS AVAILABLE.THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: Aspiration/Inhalation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137950 ↗
• MalfunctionMar 13, 2023Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device

  THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529148 ↗