CORE 5400050001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540427298), received between Feb 19, 2019 and Sep 11, 2020 — 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 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.

• MalfunctionSep 11, 2020Inability to Irrigate; Defective Component

  WE HOOKED THE CASSETTE UP AS NORMAL IT WOULD NOT IRRIGATE PROPERLY SO WE TOOK THIS CARTRIDGE OUT AND PUT IN A DIFFERENT CARTRIDGE AND IT WORKED PERFECTLY, WE DID NOTHING DIFFERENT TO THE MACHINE OR THE CARTRIDGE SO WE FEEL THIS IS A DEFECTIVE CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10520755 ↗
• MalfunctionFeb 19, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  THE USER FACILITY REPORTED THERE WAS A DIRTY PACKAGE FOUND DURING PREPARATION OF A SURGERY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351363 ↗
• MalfunctionFeb 19, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  THE USER FACILITY REPORTED THAT THERE WAS A HAIR IN THE PACKAGE FOUND DURING PREPARATION OF A SURGERY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351344 ↗
• MalfunctionFeb 19, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  THE USER FACILITY REPORTED THERE WAS A DIRTY PACKAGE FOUND DURING PREPARATION OF A SURGERY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351336 ↗