PULSAVAC® 00-5150-420-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024375130), received between Apr 18, 2022 and Aug 7, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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.

• MalfunctionAug 7, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN THE OPERATOR OPENED THE PACKAGE THERE WAS A SMALL AMOUNT OF DUST ATTACHED TO THE CENTER OF THE MAIN UNIT. OPERATOR OPENED ANOTHER DEVICE AND USED IT TO COMPLETE THE SURGERY. THERE WAS NO REPORTED PATIENT HARM OR DELAY. DUE DILIGENCE IS IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17471285 ↗
• MalfunctionApr 18, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE DEVICE STARTED MOVING SUDDENLY. THE EVENT TIMING WAS WHEN THE DEVICE WAS IN THE BOX AND NO ONE HAD TOUCHED IT. THERE WAS NO HARM OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138074 ↗