TactiCath™ A-TCSE-FFRecalls & reported problems
St. Jude Medical, Inc. · Contact Force Ablation Catheter · Class 3
All models of TactiCath (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067027658), received between Sep 20, 2022 and Feb 20, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Heart Block1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2025Fracture; Fracture
THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER DURING ANALYSIS EXPOSING INTERNAL WIRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21425637 ↗InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION, AN ATRIO-VENTRICULAR (AV) BLOCK OCCURRED CLOSE TO THE HIS BUNDLE. A PACEMAKER WAS IMPLANTED TO TREAT THE AV BLOCK.
Patient problems: Heart Block
MAUDE report 15454083 ↗
Other Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation devices
- TactiCath™ A-TCSE-DFSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall23 deaths923 reports
- TactiCath™ PN-004075St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation7 deaths338 reports
- TactiFlex™ Sensor Enabled™ A-TFSE-DFSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall6 deaths241 reports
- TactiCath™ A-TCSE-FJSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall3 deaths174 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall3 deaths147 reports
- TactiCath™ A-TCSE-DSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation2 deaths175 reports
- TactiSys™ PN-004400St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall125 reports
- QDOT MICRO D139402Biosense Webster Inc · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation3 deaths171 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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