N/A (REF 1086-259-RT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825000202), received between Mar 29, 2019 and Mar 29, 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.

• MalfunctionMar 29, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ELECTROPHYSIOLOGY CATHETER WAS VISIBLY KINKED WHEN OPENED STRAIGHT FROM THE BOX. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464936 ↗

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,