N/A (REF F6QA005CT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885825002084), received between Oct 19, 2016 and May 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CATHETER HAD NOISY SIGNALS AND THEN THE MAPPING SYSTEM COULD NOT REGISTER IT. AS REPORTED, THE DEVICE WAS REPLACED WITH AN OEM DEVICE. 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 21952743 ↗
• MalfunctionOct 19, 2016Kinked; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DEVICE MALFUNCTIONED AND HAD A KINK. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6038834 ↗

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,