TX eco EXT Cable D135703Recalls & reported problems
Biosense Webster Inc · TX eco EXT Cable · Class 3
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 10846835016796), received between Feb 23, 2026 and Feb 23, 2026 — 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
- Appropriate Device Problem Term/Code Not Available1
- Communication or Transmission Problem1
- Electrical Shorting1
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.
MalfunctionFeb 23, 2026Communication or Transmission Problem; Electrical Shorting; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE AND THERE WAS A CURRENT LEAKAGE ERROR DISPLAYED ON THE CARTO 3 SYSTEM WHEN THE PHYSICIAN TRIED TO COME ON ABLATION. THE ERROR WAS ACCOMPANIED BY SIGNAL LOSS ON ALL ELECTROCARDIOGRAM CHANNELS (BODY SURFACE AND INTRACARDIAC). THE PHYSICIAN WAS UNSURE IF THERE WAS ANY OTHER MEANS TO MONITOR THE PATIENT'S HEART RHYTHM SINCE THEY MOSTLY USE THE RECORDING SYSTEM SIGNALS. THE CABLES AND CATHETERS WERE DISCONNECTED, THEN RECONNECTED ONE BY ONE. THE ERROR RE-APPEARED WHEN THE ABLATION CATHETER CABLE WAS CONNECTED. THE CATHETER CABLE WAS REPLACED AND THE ISSUE RESOLVED. THE CASE CONTINUED. THE MEDICAL TEAM NOTED THAT THE CABLE WAS STERILMED REPROCESSED CABLE. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24411577 ↗
Other Cardiac ablation percutaneous catheter devices
- THERMOCOOL SMARTTOUCH SF D134805Biosense Webster Inc · Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- THERMOCOOL SMARTTOUCH SF D134804Biosense Webster Inc · Cardiac ablation percutaneous catheter44 deaths784 reports
- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Biosense Webster Inc · Cardiac ablation percutaneous catheter25 deaths574 reports
- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Biosense Webster Inc · Cardiac ablation percutaneous catheter8 deaths225 reports
- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 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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