TactiFlex™ Sensor Enabled™ A-TFSE-DF-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067051998), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 injury.

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 29, 2026Adverse Event Without Identified Device or Use Problem

  During a pulmonary vein isolation atrial fibrillation procedure, the patient experienced ST elevation in the precordial leads after ablating with a TactiFlex SE catheter. After delivering ablation, two mics of Isuprel were administered to try to induce PVC's post-ablation. At this time, the patient began expressing discomfort and chest pain. Fentanyl was administered by anesthesia for the pain. It was noted that no obvious changes were observed, but upon review of the case slight ST elevation was noted in some of the precordial leads. During this point of the case, the physician looked at the LV on ICE and noted that the septal wall and apex of the left ventricle were no longer contracting. Cath lab physicians were called in and confirmed occlusion near the proximal ostia of the left anterior descending artery with contrast and fluoroscopy. During the cath portion of the procedure, the patient went into Ventricular Tachycardia and had to be shocked via external defibrillators. Intravascular ultrasound was brought in, and a dissection of the proximal left anterior descending artery was confirmed. A stent was placed, and the patient's septal wall of the left ventricle began contracti

  Patient problems: Arrhythmia; Vascular Dissection

  MAUDE report 50938840 ↗

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-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-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-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
• 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