WEBSTER F6QD010RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835007930), received between Mar 29, 2023 and Mar 29, 2023 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2023Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE. HOWEVER, THE WEBSTER CS CATHETER WAS DAMAGED PRE-OPERATIVELY: THE CATHETER HAD BEEN FOUND DAMAGED WHEN THE PACKAGE WAS OPENED. THE BOX AND PACKAGING WAS NOT DAMAGED. THE INTERNAL COMPONENTS WERE EXPOSED. THE DAMAGE DID NOT RESULT IN SHARP OR LIFTED RINGS. A LIKE DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. OUT OF BOX FAILURE IS NOT MDR-REPORTABLE. INTERNAL PARTS EXPOSED IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16634068 ↗