N/A (REF F5-QF-005-RT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825001728), received between Jun 4, 2019 and Jun 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionJun 4, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DR. NOTED THE ELECTROPHYSIOLOGY CATHETER HAD A KINK IN IT AFTER IT WAS PLACED IN THE PATIENT. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8668356 ↗

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,