TX eco Cable D140102Recalls & reported problems
Biosense Webster Inc · TX eco Cable Kit · 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 10846835017427), received between Jun 13, 2024 and Jun 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Emits Odor” (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
- Device Emits Odor1
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.
MalfunctionJun 13, 2024Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A TX ECO CABLE AND A FUMES SMELL ISSUE OCCURRED. IT WAS REPORTED THAT THE PHYSICIAN SMELLED FUMES AT THE PATIENT¿S BEDSIDE, AND THE FOLLOWING ERRORS ON THE NGEN GENERATOR: 182: ELECTRODE - IMPEDANCE TOO HIGH. 170: ELECTRODE - THERMOCOUPLE DISCONNECTED, BRIEFLY APPEARED. 279: RF CABLE DISCONNECTED (CALLER CONFIRMED THIS CABLE WAS CONNECTED). 276: CARTO® - ELECTRODE PACING WARNING-CURRENTLY PACING ELECTRODE 1,2. THE CALLER WAS ADVISED TO REBOOT THE ENTIRE CARTO 3 SYSTEM AND EXCHANGE THE CATHETER CABLE AND TX ECO CABLE, NGEN WAS ALSO REBOOTED. THE STUDY WAS RELOADED, ERRORS WERE RESOLVED AND CASE WAS CONTINUED. THE CALLER CALLED BACK AND REQUESTING A REPLACEMENT TX ECO CABLE THAT WAS REPLACED. THEY BELIEVED THIS WAS CAUSING THE FUMES SMELL. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE ERROR MESSAGES WHICH POPULATED WERE ASSESSED AS NON MDR REPORTABLE. THE FUMES SMELL ISSUE WAS ASSESSED AS A MDR REPORTABLE MALFUNCTION UNDER THE TX ECO CABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19533922 ↗
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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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