NA BAR201101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888551013307), received between Dec 4, 2019 and Dec 19, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K012523); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A REPROCESSED EP DIAGNOSTIC CATHETER DYNAMIC XT STEERABLE DECAPOLAR LARGE CATHETER AND THE CATHETER CURVE WAS STUCK IN A DEFLECTED POSITION WITH FULL TENSION ON CURVED TIP AND COULD NOT BE RELAXED. A NEW DYNAMIC DECAPOLAR CATHETER WAS USED TO COMPLETE THE PROCEDURE AND THE INTENT OF THE PROCEDURE WAS NOT ALTERED AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9496263 ↗
• MalfunctionDec 4, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN EP DIAGNOSTIC CATHETER DYNAMIC XT STEERABLE DECAPOLAR LARGE AND THE DEFLECTION BECAME STUCK. DURING THE PROCEDURE, THE CURVE OF THE CATHETER WAS STUCK IN A DEFLECTED POSITION WITH FULL TENSION ON THE CURVED TIP AND COULD NOT BE RELAXED. THE DEVICE WAS CHANGED TO ANOTHER CATHETER. THE PROCEDURE WAS COMPLETED AND WAS NOT ALTERED AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412647 ↗
• MalfunctionDec 4, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER PROCEDURE WITH AN EP DIAGNOSTIC CATHETER DYNAMIC XT STEERABLE DECAPOLAR LARGE AND THE DEFLECTION BECAME STUCK. DURING THE PROCEDURE, THE CURVE OF THE CATHETER WAS STUCK IN A DEFLECTED POSITION WITH FULL TENSION ON THE CURVED TIP AND COULD NOT BE RELAXED. THE DEVICE WAS CHANGED TO A BOSTON SCIENTIFIC DYNA. THE PROCEDURE WAS COMPLETED AND WAS NOT ALTERED AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412642 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012523. 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