NA 5820010150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540346414), received between Jan 24, 2023 and Oct 23, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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 16, 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.

• MalfunctionOct 23, 2023Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987116 ↗
• MalfunctionJan 24, 2023Delivered as Unsterile Product; Expiration Date Error; Delivered as Unsterile Product; Expiration Date Error

  IT WAS REPORTED THAT EXPIRED PRODUCT WAS USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16231785 ↗
• MalfunctionJan 24, 2023Delivered as Unsterile Product; Expiration Date Error; Delivered as Unsterile Product; Expiration Date Error

  IT WAS REPORTED THAT EXPIRED PRODUCT WAS USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16231784 ↗
• MalfunctionJan 24, 2023Delivered as Unsterile Product; Expiration Date Error; Delivered as Unsterile Product; Expiration Date Error

  IT WAS REPORTED THAT EXPIRED PRODUCT WAS USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16231756 ↗