TactiSys™ PN-004515Recalls & reported problems
St. Jude Medical, Inc. · RF Cable · Class 3
All models of TactiSys (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640157990064), received between Oct 1, 2025 and Oct 1, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Communication or Transmission Problem” (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
- Communication or Transmission Problem1
- Failure to Power Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 1, 2025Failure to Power Up; Communication or Transmission Problem; Failure to Power Up; Communication or Transmission Problem
DURING A PROCEDURE, THERE WAS AN AMPERE GENERATOR BOOT UP ISSUE AND AN ERROR DISPLAYED STATING "GENERATOR MALFUNCTION". RESTARTING THE AMPERE GENERATOR DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS THEN CANCELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23187806 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page