NA BAR201007Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551013284), received between Oct 5, 2020 and Oct 5, 2020 — classified as 1 malfunction.

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

• MalfunctionOct 5, 2020Contamination; Contamination

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A EP DIAGNOSTIC CATHETER EP XT STEERABLE DECAPOLAR LARGE 4.0 AND AFTER THE PROCEDURE, AN UNKNOWN MATERIAL WAS ATTACHED TO THE TIP. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10627984 ↗

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