TactiCath™ A-TCSE-JJRecalls & reported problems
St. Jude Medical, Inc. · Contact Force Ablation Catheter · Class 3
All models of TactiCath (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067027672), received between Mar 2, 2022 and Mar 2, 2022 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING AN ATRIAL FIBRILLATION/LEFT ATRIAL FLUTTER ABLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED. MID CASE, THE ABLATION CATHETER WAS NOTED OUT OF THE GEOMETRY SURFACE. THE PATIENT STATUS BEGAN TO DECREASE, AND ICE IMAGES SHOWED AN EFFUSION. THE PATIENT WAS CARDIOVERTED TO SINUS RHYTHM AND THE EFFUSION WAS MONITORED VIA ICE AND TRANSESOPHAGEAL ECHOCARDIOGRAM FOR APPROXIMATELY 30 MINUTES. THE PATIENT WAS CONSIDERED TO BE STABLE AND TRANSFERRED TO UNIT. THE PATIENT RETURNED TO CATH LAB LATER FOR A PERICARDIOCENTESIS AND IS IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.
Patient problems: Cardiac Perforation
MAUDE report 13654577 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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