N/A (REF F6QF005CT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825002183), received between Sep 11, 2024 and Sep 11, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (1 report).

1 other recall cover devices cleared under the same FDA submission (K030109); they may or may not involve this specific model.

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.

• MalfunctionSep 11, 2024Device Damaged Prior to Receipt by User; Use of Device Problem; Material Twisted/Bent; Device Damaged Prior to Receipt by User; Use of Device Problem; Material Twisted/Bent

  IT WAS REPORTED THERE WAS A DEFECTIVE CATHETER IN A CASE. IT LOST ITS ABILITY TO KEEP THE CURVE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195962 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030109. One submission often covers many models, so check the product and lot details in each record.

• Z-0340-2014 · Oct 18, 2013 · Terminated
  Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT,