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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024375024), received between Apr 27, 2023 and Jul 7, 2023 — classified as 4 malfunctions.

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

• MalfunctionJul 7, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT THERE ARE METAL EXPOSED WIRES. THE EVENT TIMING IS OUTSIDE OF SURGERY. THERE IS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279638 ↗
• MalfunctionJul 7, 2023Material Frayed; Material Frayed

  THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279271 ↗
• MalfunctionApr 27, 2023Break; Material Frayed; Break; Material Frayed

  THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827834 ↗
• MalfunctionApr 27, 2023Break; Material Frayed; Break; Material Frayed

  THERE IS NO EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16826086 ↗