NA DAI401905Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551008839), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 malfunction.

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.

• MalfunctionAug 16, 2023

  MIDDLE-AGED MALE WITH HISTORY OF HTN (HYPERTENSION), MORBID OBESITY AND ATRIAL FIBRILLATION. PROCEDURE: ABLATION WITH CARTO. THE DUO-DECAPOLAR CATHETER WOULD NOT STEER. UNABLE TO BE USED SO IT WAS REMOVED WITHOUT DIFFICULTY. A NEW DEVICE WAS USED WITHOUT FURTHER ISSUES. NO KNOWN HARM TO PATIENT, MINOR DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR CATHETER, RECORDING, ELECTRODE, REPROCESSED, NA (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555482 ↗

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