TactiSys™ Quartz Equipment TSQ-RF-TFSE-CBLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067034700), received between Sep 12, 2025 and Sep 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Signal Artifact/Noise” (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 18, 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.

• MalfunctionSep 12, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THERE WERE ISSUES WITH NOISE ON THE ECG RESULTING IN CANCELLATION OF THE PROCEDURE. MAPPING AND ABLATION WERE PERFORMED, BUT CONSOLIDATION WAS NEEDED. THE PATIENT HAD BEEN SEDATED DURING ABLATION AS THEY WERE EXPERIENCING PAIN. THE PRS-PS MOVED SO MAPPING WAS PERFORMED AGAIN. AT THIS TIME, THERE WAS A LOT OF NOISE ON THE ECG. THE NOISE WAS NOT ABLE TO BE RESOLVED, AND IT WAS DECIDED TO END THE PROCEDURE DUE TO NOT BEING ABLE TO MAP AND PACE THE PREMATURE VENTRICULAR CONTRACTION. IT IS UNKNOWN WHAT WAS CAUSING THE ISSUE. UPON CLEAN UP THE NOISE ON THE ECG DISAPPEARED WHEN REMOVING THE TACTIFLEX CABLE FROM THE TACTISYS. THE CABLE WAS RECONNECTED, BRINGING BACK THE NOISE, AND THEN DISCONNECTED AND THE NOISE RESOLVED ONCE AGAIN. IT IS UNKNOWN WHAT WAS CAUSING THIS AS THE TACTIFLEX WAS USED FOR MAPPING AT THE BEGINNING OF THE PROCEDURE WITHOUT ISSUE. THE TACTISYS AND TACTIFLEX TO TACTISYS CABLE HAVE BOTH BEEN USED IN PROCEDURES SINCE WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042746 ↗

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