NA EPT7005DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551010771), received between May 3, 2019 and May 3, 2019 — 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.

• MalfunctionMay 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER PROCEDURE WITH AN EP CATHETER DIAGNOSTIC POLARIS X STEERABLE DECAPOLAR 270DEG STANDARD CATHETER, AND THE TIP BECAME PARTIALLY SEPARATED FROM THE SHAFT. AFTER THE DEVICE WAS REMOVED THE PATIENT, IT WAS NOTICED THAT THE TIP WAS SEPARATED FROM THE SHAFT AND INTERNAL COMPONENTS WERE EXPOSED WHICH HELD THE CATHETER TIP TO THE SHAFT TO PREVENT A FULL SEPARATION. THERE WAS NO DELAY, MEDICAL INTERVENTION OR PATIENT CONSEQUENCE. THE PROCEDURE WAS CANCELED DUE TO NON-INDUCTION BECAUSE THE PATIENT WAS IN ATRIAL FIBRILLATION AND DID NOT ACTUALLY HAVE A FLUTTER. THIS CANCELLATION WAS UNRELATED TO THE CATHETER ISSUE. THIS EVENT HAS BEEN ASSESSED AS A REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8580255 ↗

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