TactiFlex™ Sensor Enabled™ A-TFSE-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067034694), received between Sep 9, 2025 and Sep 9, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

5 other recalls cover devices cleared under the same FDA submission (P220013); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING AN ACCESSORY PATHWAY ABLATION PROCEDURE, AN AIR EMBOLISM OCCURRED WHICH RESULTED IN AN ARRHYTHMIA AND REQUIRED COMPRESSIONS TO STABILIZE THE PATIENT. WHILE WORKING AROUND THE LEFT VENTRICULAR SUMMIT AREA WITH THE ABLATION CATHETER, AFTER MANY LESIONS HAD BEEN PERFORMED, A 'BUBBLE DETECTED' MESSAGE WAS NOTED FROM THE AMPERE INDICATING THAT THERE WAS A COOL POINT PUMP BUBBLE DETECTED. THE IRRIGATION FLUID BAG HAD RUN OUT AND NEEDED TO BE REPLACED. THE ABLATION CATHETER WAS IN A PROPER LOCATION TO ABLATE AROUND THE LEFT ATRIAL APPENDAGE, THUS IT WAS NOT GOING TO BE REMOVED OUTSIDE THE PATIENT TO FLUSH AND INSTEAD THE FLUSH WOULD HAPPEN FROM CLOSING THE STOPCOCK TO THE PATIENT. WHEN THE FLUID BAG WAS REPLACED, THE STOPCOCK WAS ACCIDENTALLY LEFT OPEN AND FLUSHED WITH THE CATHETER STILL IN THE HEART, LEADING TO INTRODUCTION OF AIR BUBBLES. THE PATIENT WAS BELIEVED TO HAVE AN AIR EMBOLISM, AS THEY WENT INTO A VENTRICULAR ESCAPE RHYTHM AND ANESTHESIA VITALS DROPPED. CHEST COMPRESSIONS WERE PERFORMED, THE PATIENT STABILIZED AND RETURNED TO NORMAL RHYTHM. THE REMAINDER OF THE CASE WAS ABORTED, AND THE ACCESSORY PATHWAY WAS NOT SUCCESSFULLY ABLATED. THE PATIENT WOKE UP FROM ANESTHESIA

  Patient problems: Air Embolism; Arrhythmia

  MAUDE report 23009813 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P220013. One submission often covers many models, so check the product and lot details in each record.

• Z-0110-2026 · Sep 10, 2025 · Open, Classified
  TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
• Z-0111-2026 · Sep 10, 2025 · Open, Classified
  TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
• Z-0113-2026 · Sep 10, 2025 · Open, Classified
  TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
• Z-0112-2026 · Sep 10, 2025 · Open, Classified
  TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
• Z-0109-2026 · Sep 10, 2025 · Open, Classified
  TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter