NA DAI401941Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551008990), received between Dec 14, 2021 and Dec 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K051220); 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.

• MalfunctionDec 14, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION PROCEDURE WITH A REPROCESSED EP DIAGNOSTIC CATHETER LIVEWIRE DECA EXTRA LARGE CURL AND THERE WAS A SEPARATION WHERE THE LAST ELECTRODE CONNECTS TO THE SHAFT OF THE CATHETER WITH INTERNAL COMPONENTS EXPOSED. THE PACKAGE WAS OPENED AT THE TIME THE PHYSICIAN REQUESTED THE DEVICE FOR USED, HOWEVER, IT IS UNKNOWN IF THERE WAS ANY PHYSICAL DAMAGE TO THE PACKAGING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002698 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051220. One submission often covers many models, so check the product and lot details in each record.

• Z-0555-2009 · Aug 8, 2008 · Terminated
  EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904 DAI401915 and EPT7003D Intended for temporary use during electrophysiology studies for intrac