Dynamic Tip™ M0046DYNTP0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729879848), received between Nov 30, 2023 and Nov 28, 2025 — classified as 1 injury, 2 malfunctions.

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

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

• MalfunctionNov 28, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CATHETER TIP WAS FRACTURED. DURING A RADIOFREQUENCY ABLATION PROCEDURE TO TREAT ATRIAL ARRHYTHMIA IN THE LEFT ATRIUM, A DYNAMIC TIP ELECTRODE CATHETER WAS USED. WHEN ATTEMPTING TO INSERT THE CATHETER, IT WAS OBSERVED THAT THE TIP WAS FRACTURED. ANOTHER DYNAMIC TIP ELECTRODE CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS STABLE FOLLOWING THE PROCEDURE. THE DEVICE HAS BEEN RECEIVED AND ANALYZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671761 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION, BLOOD LOSS & CARDIAC TAMPONADE. DURING A REDO PULMONARY VEIN ISOLATION PROCEDURE, A DYNAMIC TIP STEERABLE DIAGNOSTIC CATHETER WAS SELECTED FOR USE. SCAR TISSUE AT THE ANTERIOR WALL OF THE PATIENT WAS OBSERVED, THEREFORE, ABLATION ON THE ANTERIOR MITRAL LINE (RIGHT SUPERIOR PULMONARY VEIN TO ANTERIOR MITRAL ANNULUS) WAS PERFORMED. TO CHECK IF THE LINE WAS COMPLETELY ISOLATED, THE PHYSICIAN PLACED THE 10 POLE DYNAMIC TIP CATHETER (USED AS CORONARY SINUS CATHETER BEFORE) IN THE LEFT ATRIAL APPENDAGE (LAA) AND WENT FOR PACED MAPPING. PACE WAS DONE FROM THE MOST DISTAL ELECTRODE PAIR (CS 1/2). A GAP WAS NOTICED; THEREFORE, THIS AREA WAS RE-ABLATED AND WENT FOR THE SECOND RE-MAP (THE DYNAMIC TIP CATHETER STAYED IN THE LAA DURING RE-ABLATION). THE PHYSICIAN WANTED TO MAP AGAIN UNDER DISTAL PACING FROM THE DIAGNOSTIC CATHETER, BUT SUDDENLY, THERE WAS NO CAPTURE. ANOTHER ELECTRODE PAIR (CS 7/8) WAS CHOSEN, AND RE-MAP WAS PERFORMED. AS ALL ABLATION SITES WERE ISOLATED THE PROCEDURE WAS FINISHED AND THE PATIENT GOT A PRESSURE BANDAGE AND WAS SENT TO THE OBSERVATION UNIT. AFTER 20 MINUTES, THE LAB WAS CALLED AGAIN AND TOLD TH

  Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion

  MAUDE report 19080908 ↗
• MalfunctionNov 30, 2023Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS FRACTURED. DURING A RADIOFREQUENCY ABLATION PROCEDURE, A DYNAMIC TIP ELECTRODE CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT THE JUNCTION OF THE CATHETER WAS KINKED. ALSO, WHEN UNPACKING THE DEVICE, IT WAS NOTICED THE TIP OF THE CATHETER WAS FRACTURED. DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER IS EXPECTED TO BE RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242084 ↗